GUIDELINES FOR THE PREVENTION AND TREATMENT OF VENOUS THROMBOEMBOLISM (VTE) IN MEDICAL AND SURGICAL INPATIENTS ON THE MDGH SITE

Transcription

1 GUIDELINES FOR THE PREVENTION AND TREATMENT OF VENOUS THROMBOEMBOLISM (VTE) IN MEDICAL AND SURGICAL INPATIENTS ON THE MDGH SITE This local guideline has been produced as an aid to risk assessment and prevention of VTE based on NICE clinical guideline 92 (Venous Thromboembolism: reducing the risk January 2010) and DoH National VTE Risk Assessment Tool 2010, and treatment of VTE based on NICE clinical guideline 144 (The management of venous thromboembolic diseases and the role of thrombophilia testing) Every patient should be assessed individually before applying guidance on thromboprophylaxis NICE CG 92 does not apply to patients in intermediate care beds. All patients admitted to intermediate care beds should be assessed by intermediate care clinicians on individual patient merit. A datix should be completed for any occurrence of VTE in a patient occupying an intermediate care bed.

2 Policy Title: Guidelines for the Prevention and Treatment of Venous Thromboembolism in Medical and Surgical Inpatients Executive Summary: This policy provides guidance to aid risk assessment, prevention and treatment of venous thromboembolism in medical and surgical inpatients Supersedes: Previous Version 7 Nov 2015 Description of Amendment(s): Version 3 changes Removal of 4 hour time limit for VTE assessment on admission Procedure to be followed in event of cancellation of surgery added. Removal of routine administration of low-molecular weight heparin prophylaxis the day prior to surgery for enhanced recovery patients. SOP removed from guideline. Apixaban now preferred agent for prophylaxis following hip and knee replacement, changed from rivaroxaban. Change to monitoring requirements of LMWH for HIT and removal of GP letter asking platelets to be checked. Maternity thromboprophylaxis forms updated Version 4 changes ( Feb 2013) Addition of root cause analysis investigation Change of recommendation for timing of post op tinzaparin in surgical patients from 6-8 hrs post op to at least 4 hours post op at the discretion of the clinician Version 5 changes (July 2014) Change of recommendation for timing of post op tinzaparin in surgical patients from 6-8 hrs post op to at least 6 hours post op at the discretion of the clinician Time limit for VTE assessment on admission defined as 12 hours Version 6 changes (July 2015) For patients who are concurrently on drugs that interact with apixiban (as listed in the SPC) see section 6.11 (apixiban additional information), the patient will be prescribed tinzaparin 4500units once daily post-operatively. Change from CHADS2 scoring system of stroke risk in patients with AF to CHA 2 DS 2 VASc scoring system. Guidance for stopping and starting New Oral Anticoagulants (NOAC s) in the peri-operative period added appendix 5 Addition of tinzaparin shared care guidance Appendix 6 Addition of requirement to monitor potassium levels in high risk patients on tinzaparin Addition of Root Cause Analysis form for Hospital Associated Thrombosis Appendix 7 Addition of district nurse guidance on self-administration of tinzaparin Appendix 8 Addition of definition of cohort groups at ECT Appendix 9 Addition of PE treatment pathway Appendix 10 Addition of DVT treatment pathway Appendix 11 Addition of Compliance Monitoring Tool as Appendix 12 Addition of statement that VTE policy does not apply to

3 intermediate care patients. For patients weighing>100kg, increase tinzaparin dose to 50units/kg for prophylaxis of VTE (section 7.5) For all patients weighing < 50kg, tinzaparin dose reduced to 2500 units once daily (section 7.5) Recommendation for use of the geko device (section 7.4) and IPC in acute stroke as per NICE CG update June 2015 Recommendations for prescribing of prophylactic tinzaparin for fractured neck of femur patients on the enhanced recovery programme (section 7.10) Addition of information on timing of administration of apixaban following hip and knee replacement Time limit for VTE assessment on admission defined as 24 hours Version 7 changes Inclusion of cohort policy (appendix 9) Update of tinzaparin shared care guidance (appendix 6) to include revised dosing regime for patients >100kg Update of guidance for Perioperative Management of Patients on Anticoagulant Therapy who Require Urgent Surgery (Appendix 2) Version 8 changes Update of guidance for Perioperative Management of Patients on Anticoagulant Therapy who Require Urgent Surgery (Appendix 2) Added statement: for patients admitted after 6pm, consider prescribing a stat dose of tinzaparin This policy will impact on: All staff who have clinical responsibility for the risk assessment, prevention and treatment of venous thromboembolism Related Policies: Venous Thromboembolism in Pregnancy and the Puerperium Trust Guideline Financial Implications: None Policy Area: Venous Document Reference: Thromboembolism Version Number: 8 Effective Date: March 2016 Issued By: Author: Chair of Medicines Management Group Medicines Management Pharmacist Review Date: February 2019 Impact Assessment Date: Consultation: APPROVAL RECORD Committees / Group Date Venous Thromboembolism (VTE) group June 2015 and October 2015 Approval Committee Medicines Management Group(MMG) March 2016 Ratified by Committee/ Executive Director: Received for information: Medical Director Service Line Unit SQS

4 CONTENTS Page Policy Control Page 3 1. Introduction 4 2. Policy Statement 4 3 Scope 4 4. Roles and Responsibilities Implementation 5 6. Training Needs Analysis 7. Local VTE guidelines Measuring performance Audit Review References 15 Appendices Appendix 1 On admission and 24 hour VTE Risk Assessment Form and Weekly VTE Risk Assessment Form for Adult Inpatients and Day-case patients Appendix 2 Peri-op anticoagulation guidelines for elective surgical patients on anticoagulant treatment Flow chart for managing cancelled elective surgical patients on anticoagulant treatment Peri-operative management of patients on anticoagulant therapy who require urgent surgery Appendix 3 Guidelines for use of compression stockings and IPC Appendix 4 Risk Assessment Forms for Obstetrics Appendix 5 Guidance for stopping and starting NOAC s in the peri-op period Appendix 6 Shared care protocol for tinzaparin Appendix 7 Root Cause Analysis Form for hospital associated thrombosis Appendix 8 Pathway for District Nurse administration of tinzaparin

5 Appendix 9 Definition of Cohort Groups at ECNHST Appendix 10 Treatment of PE and massive PE pathway Appendix 11 Treatment of DVT pathway Appendix 12 Compliance Monitoring Tool Appendix 13 Equality Analysis Throughout this document, East Cheshire NHS Trust is referred to as the Trust.

6 1. Introduction The House of Commons Health Committee reported in 2005 that an estimated 25,000 people in the UK die from preventable hospital-acquired venous thromboembolism (VTE) every year. This includes patients admitted to hospital for medical care and surgery. The inconsistent use of prophylactic measures for VTE in hospital patients has been widely reported. A UK survey suggested that 71% of patients assessed to be at medium or high risk of developing deep vein thrombosis did not receive any form of mechanical or pharmacological VTE prophylaxis. Treatment of non-fatal symptomatic VTE and related long-term morbidities is associated with considerable cost to the health service. The risk of developing VTE depends on the condition and/or procedure for which the patient is admitted and on any predisposing risk factors It is therefore important to assess all hospital inpatients for their risk of VTE in order to determine which of them need additional prophylaxis. NICE Clinical Guidance 92 Reducing the risk of venous thromboembolism in patients admitted to hospital January 2010, sets out recommendations on assessing and reducing the risk of VTE Based on this guidance the Department of Health produced a national risk assessment in April This local guideline has been produced based on these best practice guidelines. 2. Policy Statement The purpose of this policy is to provide clear guidance to clinical staff on: Venous Thromboembolism (VTE) risk assessment to identify patients at risk. Selecting the appropriate level of prophylaxis for the prevention of VTE for those patients identified at risk. Following the appropriate treatment pathway for those patients with a suspected or positive diagnosis. 3. Scope This policy applies to: All staff with clinical responsibility for VTE risks assessment prevention and treatment All adult patients (18 or over) who require hospitalisation which includes day case patients with the exception of patients who fit the profile of a cohort group see Appendix 9 4. Roles and responsibilities 4.1 Chief Executive Has overall responsibility for ensuring that the Trust has appropriate policies in practice and that robust monitoring arrangements are in place. 4.2 Director of Corporate Affairs and Governance Has the delegated responsibility for ensuring that appropriate arrangements are in place to ensure robust policy governance across the Trust.

7 4.3 Medical Director Has Trust Board accountability for providing assurance that local VTE policies and procedures are compliant. The Medical Director will hold Clinical Directors responsible for the effective implementation of this policy within their respective Service Lines 4.4 Clinical Directors and Heads of Service Have responsibility for: having systems in place to monitor key performance indicators associated with VTE, to manage non-compliance and escalate associated risk where appropriate. receiving and responding to policy cascades within designated timescales. the onward cascade to staff, of information regarding newly developed and reviewed documentation received via the Policy Cascade system and maintaining an audit trial of cascade. 4.5 Medicines Management Group (MMG) MMG is responsible for approving the VTE policy. The committee will identify any changes to the policy and allocate responsibility for amendments to the VTE group. Amended policy documents will be approved by the committee. The committee will review the policy every three years or sooner if needed. 4.7 Venous Thromboembolism Group (VTE Group) The purpose of the VTE Group is: To develop, initiate and monitor a clear framework to ensure that the Trust can demonstrate delivery and compliance of the National VTE prevention programme. To monitor and report on the compliance and assurance of the implementation of clinical processes relating to VTE assessment and treatment, according to national and local policy and guidelines. To ensure that there is a process in place for the service lines to receive monthly information on their KPI s contained within VTE assessment and treatment and that plans are fit to achieve goals To ensure that all incidents relating to a hospital acquired VTE event are subject to root cause analysis, undertaken by the responsible service line, and action plans are received by the VTE group for assessment and assurance To agree the education and training programme on VTE assessment for identified clinical and nursing staff To ensure that any barriers to the implementation of recommended actions required by National Policy, or in relation to national and local audits where changes in practice are required, are highlighted and addressed, escalating any unresolved issues to the service line and Trust Quality Strategy Group. 4.8 Line Managers Line Managers are responsible for bringing to the attention of their staff, the publication of a new or updated policy. retaining evidence that the information relating to a newly developed and amended document has been cascaded within their team / department ensuring the new document is operationally implemented ensuring that their staff complete appropriate VTE training and appropriate records are maintained

8 4.9 All East Cheshire NHS Trust Staff Staff are responsible for: accessing the relevant procedural documents as directed by their managers informing their line manager, and where appropriate escalating with the Business Unit management team, failure to receive procedural document information as set out in this policy. completing all relevant training as required Root cause analysis A root cause analysis (RCA) will be undertaken within the service line for any hospital acquired VTE. RCA reports and action plans will be monitored by service line SQS and will be received by the VTE group for assessment and assurance. 5.0 Implementation 5.1 This policy will be uploaded onto the Trust internet and an containing a link to the policy will be sent to all staff. 5.2 It is the line manager s responsibility to inform their staff of any changes to this policy. 6.0 Training Relevant staff will attend training as identified in the Trust Training Needs Analysis and staff attendance will be detailed in mandatory training reports 7.0 Local VTE guidelines 7.1 General Recommendations 7.2 Risk Factors for VTE 7.3 Recommendations for Mechanical Prophylaxis 7.4 Recommendation for use of Geko Device 7.5 Recommendations for Pharmacological VTE Prophylaxis (Tinzaparin) o Dosing In renal impairment o Monitoring Requirements and Heparin Induced Thrombocytopenia (HITs) o Dose adjustment for extremes of body weight o Reversibility of Tinzaparin 7.6 Review of thromboprophylaxis 7.7 Peri-operative management of patients on anticoagulants 7.8 Patients admitted or discharged on antiplatelet therapy 7.9 Recommendations for General and Gynaecological Surgery o Enhanced bowel recovery programme o Major cancer surgery in the abdomen and pelvis o Day surgery o Breast Surgery 7.10 Recommendations for Major Orthopaedic Surgery o Hip Fracture Surgery o Total Hip Replacement o Total Knee Replacement o Fracture neck of femur enhanced recovery patients 7.11 Lower Limb Plaster Casts 7.12 Apixaban additional information 7.13 Spinal / Epidural Anaesthesia 7.14 Thromboprophylaxis in Medical Patients 7.15 Recommendations in Pregnancy and post-partum 7.16 Recommendations for Pharmacological treatment of VTE

9 7.1 GENERAL RECOMMENDATIONS: All patients: Should have a documented risk assessment for VTE on admission - on admission refers to the 24 hour period from the decision made to admit. Should be re-assessed for risk of VTE within 24 hours of admission and then every 7 days unless the clinical situation dictates an earlier assessment. This must be documented. Should receive thromboprophylaxis, according to the degree of VTE risk balanced against risks of bleeding, at least until discharge. Some patients will require extended (post discharge) VTE prophylaxis in accordance with NICE guidance. Should be assessed for contra-indications to heparin. Should be given verbal information on the risks of VTE and effectiveness of prophylaxis pre and post discharge. Written information is also available to give to patients and is available on trust net. For patients discharged home with VTE prophylaxis, ensure the patient has received appropriate training and is able to use the VTE prophylaxis at home, or have someone available to help them. It is the prescriber s responsibility to annotate the front of the drug chart with the patient s weight before prescribing tinzaparin prophylactic or treatment dose For a patient that is bleeding on admission and decision is made not to prescribe tinzaparin, best practice would be to clearly document timely review of tinzaparin and regularly document decision to prescribe or not to prescribe tinzaparin. The decision should be clearly documented in the patient s medical notes. In addition: Do not allow patients to become dehydrated unless clinically indicated Encourage patients to mobilise as soon as possible Do not regard aspirin or other antiplatelet agents as adequate prophylaxis for VTE Consider offering temporary inferior vena cava filters to patients who are at very high risk of VTE (such as patients with a previous VTE event or active malignancy) if mechanical and pharmacological VTE prophylaxis contraindicated Patients having elective surgery: Should be advised to consider stop taking combined oral contraceptives or HRT 4 weeks before elective surgery, see East Cheshire Peri-operative Drug Management Guidelines on trust internet for further information Should be VTE risk assessed before admission in the pre-op clinic to anticipate any action needed and at admission to ensure that there has been no change. Assess risks and benefits of stopping antiplatelet therapy 1 week before surgery. See East Cheshire Peri-operative Drug Management Guidelines on trust internet. For patients with coronary stents, please follow guidance within Peri-operative Drug Management Guidelines. In the event of surgery being cancelled and the patient is taking anticoagulants follow appendix 2.

10 7.2 RISK FACTORS FOR VENOUS THROMBOEMBOLISM PATIENT FACTORS Age > 60 years Obesity (BMI > 30kg/m 2 ) Varicose veins with phlebitis Immobility ( bed rest over 3 days ) Pregnancy and < 6 weeks post-partum Smoking Use of HRT or oestrogen containing contraceptive therapy Personal history or first degree relative with a history of VTE Thrombophilia Deficiency(s) of : Antithrombin III Protein C Protein S Antiphospholipid antibody Lupus anticoagulant Dehydration DISEASE OR SURGERY Malignancy especially pelvic, metastatic or abdominal Critical care admission Heart failure Recent myocardial infarction Paralysis of lower limb(s) Infection Inflammatory bowel disease Nephrotic syndrome Polycythaemia Paraproteinaemia Paroxysmal nocturnal haemoglobinuria Behçets disease Homocystinaemia Surgical patients and patients with trauma If total anaesthetic + surgical time> 90 minutes OR If surgery involves pelvis or lover limb and total anaesthetic + surgical time > 60 minutes OR If acute surgical admission with inflammatory or intra-abdominal condition OR If expected to have significant reduction in mobility OR If any VTE risk factor present NICE Clinical Guideline 92, Venous Thromboembolism: reducing the risk January Recommendations for Mechanical Prophylaxis All inpatients having surgery should receive anti-embolism stockings (TEDs) OR intermittent pneumatic compression (IPC) unless contra-indicated. Medical patients to receive anti-embolism stockings if appropriate. In patients admitted for stroke do not offer TEDs. See Appendix 3 for guidance on correct use of TEDs and IPC TEDs and IPC may be considered as an adjunct to heparin prophylaxis. Use mechanical prophylaxis if pharmacological prophylaxis (tinzaparin) is contra-indicated NICE CG 92 update published in June 2015 recommends that IPC should be considered for VTE prophylaxis in immobile patients who are admitted within 3 days of acute stroke. The NICE guidance update recommends the following: Explain to the patient or their family members or carers (as appropriate) that: o It reduces the risk of DVT and may provide an increase in survival o It will not help them recover from stroke, and there may be an associated increased risk of surviving with severe disability When using IPC for patients who are admitted for stroke, provide it for 30 days or until the patient is mobile or discharged, whichever is sooner. 7.4 Recommendation for use of Geko device The Geko is a battery powered, disposable, neuromuscular electrical stimulation device designed to increase blood flow in the veins of the leg, reducing the risk of VTE. The geko device stimulates

11 the common peroneal nerve activating the calf and foot muscle pumps in order to increase venous, arterial and microcirculatory blood flow. The VTE group supports the use of the Geko device as per NICE medical technology guidance 19: The Geko device for reducing the risk of venous thromboembolism June The NICE guidance recommends the following: The case for adopting the Geko device is supported for use in people who have a high risk of venous thromboembolism and for whom other mechanical and pharmacological methods of prophylaxis are impractical or contraindicated. Although clinical evidence is limited, the case is supported because of the plausibility that the Geko device may reduce the high risk of venous thromboembolism in patients who cannot use other forms of prophylaxis and the low risk of the device causing harm. However, NICE CG 92 update published in June 2015 states that the Geko device should NOT be offered for VTE prophylaxis to patients who are admitted for stroke except in the context of research. 7.5 Recommendations for Pharmacological VTE Prophylaxis LMWH of choice for VTE prophylaxis in East Cheshire NHS Trust is tinzaparin. Usual Dose : 4500 units once daily. Where possible, the tinzaparin should be prescribed at 6.00pm. However, for patients admitted after 6pm, consider prescribing a stat dose of tinzaparin. Contra-indications to tinzaparin include (see SPC for full details): o Known hypersensitivity to tinzaparin o Generalised haemorrhagic tendency o Severe liver insufficiency o Intracranial haemorrhage o Uncontrolled severe hypertension o Active peptic ulcer o Septic endocarditis o Current or history of heparin-induced thrombocytopenia (HIT) Dosing in Renal Impairment o In severe renal impairment ( egfr < 20mls/min) reduce the dose of tinzaparin to 3,500 Units daily. Monitoring Requirements and Heparin Induced Thrombocytopenia (HIT) o Regular potassium monitoring is required in high risk patients i.e.diabetes mellitus, chronic renal failure, acidosis, raised potassium levels, patients taking potassiumsparing drugs or potassium supplements or patients on long-term treatment (minimum annually or more frequently as appropriate) o o o o o HIT is a possible complication of treatment with LMWH. The immune-mediated type usually occurs 7-11 days (up to 20 days) after initiating treatment Patients who are to receive any type of heparin require a baseline platelet count. All patients on LMWH require a baseline platelet count but no monitoring is required following treatment unless clinically indicated (e.g. following cardiopulmonary bypass) or if the patient has received heparin in the preceeding 100 days. Post operative patients and cardiopulmonary bypass patients who have been exposed to heparin in the previous 100 days should have a platelet count determined 24 hours after starting heparin. Medical patients receiving heparin do not need routine platelet monitoring.

12 o If the platelet count falls by 30% or more and/or the patient develops new thrombosis or skin allergy or any of the other rarer manifestations of HIT between days 4 and 14 of heparin administration, HIT should be considered and a clinical assessment made. (Ref - Guidelines on the diagnosis and management of heparin-induced thrombocytopenia: second edition Vol 159 Issue 5 pg British Journal of Haematology 2012) o NOTE The Royal College of Obstetricians and Gynaecologists Green-top guideline No 37, November 2009 recommends that obstetric patients on prophylactic doses of LMWH do not require routine platelet monitoring. The requirement to monitor platelets in obstetric patients is at the discretion of the Consultant Obstetrician managing the patient. See Venous Thromboembolism in Pregnancy and the Puerperium, Trust guidelines on Trust intranet. Adjustment of prophylactic dose for weight o For patients weighing more than 100kg increase prophylactic dose of tinzaparin to 50 units per kg bodyweight once daily as per table below. Note that this advice does not apply to pregnant patients. For patients weighing more than 100kg and egfr<20ml/min seek advice from the consultant haematologist with regard to dose adjustment. o For all patients weighing less than 50kg, reduce prophylactic dose to 2500 units once daily. Dosing of Tinzaparin for Prophylaxis of VTE Bodyweight (kg) Prescribed Dose Tinzaparin(IU) Tinzaparin Syringe Size (give once daily) (units) < 50 2,500 2, ,500 4, ,000 2 x 2, ,000 2, , ,000 2 x 3, ,000 3, , ,000 2 x 4,500 o For obstetric patients, see Venous Thromboembolism in Pregnancy and the Puerperium, Trust guidelines on Trust intranet. Reversibility of Tinzaparin o Protamine Sulphate 1mg per 100 anti-xa units tinzaparin administered should be given over 10 minutes. This neutralises approximately 65% to 85% of the anti-xa activity almost immediately. This can be administered at any time up to and including 3 hours after tinzaparin administration. o A partial return of tinzaparin s anti-xa, anti-iia and APTT activities (to 76%, 58% and 44% of original) is seen 3 hours after reversal. Repeat protamine doses or an infusion may be required. Suggested timescales for repeat injections are minutes after first injection and if necessary every 60 minutes thereafter until APTT

13 normalises. o If protamine sulphate is first administered later than 3 hours after tinzaparin administration, an adjustment in dosage may be considered to reflect decreasing tissue levels of tinzaparin 7.6 Review of Thromboprophylaxis All in-patients should have a documented VTE risk assessment on admission using the Trust VTE Risk Assessment Proforma (See Appendix 1). The admitting doctor or non medical prescriber is responsible for completing the risk assessment and prescribing thromboprophylaxis (including TED s) in the prescription chart as appropriate. The date and time must be clearly documented on the VTE assessment form and prescription chart (see Appendix 1) In pregnancy or less than six weeks post partum, use separate VTE risk assessment see Trust guidance for VTE during pregnancy, labour and postnatally. If thromboprophylaxis is not required, the pre-printed prescription for LMWH should be crossed off in the drug chart. The VTE risk assessment should be repeated within 24 hours of date and time of admission to ensure the treatment plan is still appropriate. All patients VTE risk assessment should be repeated weekly unless the clinical situation dictates an earlier assessment. For further weekly VTE risk assessments, use the separate weekly VTE risk assessment proforma see Appendix 1) The responsible clinician or non medical prescriber should sign and date the VTE Risk assessment, as appropriate, every time a risk assessment is completed. 7.7 Peri-operative management of patients oral anticoagulants Patients on oral anticoagulants for a high risk indication (e.g. mechanical heart valves) should follow the guideline for the peri-operative management of patients on anticoagulants and should be prescribed a treatment dose of tinzaparin post-operatively instead of a prophylactic dose of LMWH or apixaban - see appendix 2. Patients on anticoagulation for a low risk indication (e.g. Atrial Fibrillation with a CHA 2 DS 2 VASc score < 6) should be prescribed prophylactic dose of tinzaparin postoperatively and continued until oral anticoagulation is within the therapeutic range -see appendix 2 If surgery is cancelled please follow flow chart in appendix Surgical Patients Admitted or Discharged on Antiplatelet Therapy For patients on antiplatelet therapy (aspirin, dipyridamole and/or clopidogrel/ ticagrelor/ prasugrel) please refer to the Peri-operative Drug Management Guidelines for management of these patients If antiplatelet therapy is stopped during admission, it is usually restarted on discharge (usually 4 to 5 days post-op)

14 To reduce the risks of gastrointestinal bleeding: o o Patients discharged on extended thromboprophylaxis (tinzaparin or apixaban) and an antiplatelet eg aspirin, dipyridamole, clopidogrel, ticagrelor, prasugrel will also be prescribed lansoprazole 30mg daily for the duration of thromboprophylaxis. Concomitant use of NSAID s and tinzaparin or apixaban on discharge, should be avoided if possible. In medical patients who are prescribed thromboprophylaxis, the antiplatelet therapy should normally continue unless the patient is considered to be at high risk of bleeding 7.9 Recommendations for General and Gynaecological Surgery WHERE POSSIBLE PRESCRIBE TINZAPARIN AT 6.00pm For all patients: Maintain hydration Ensure early mobilisation Use correctly fitted TED stockings OR IPC If LMWH not contraindicated, use Tinzaparin 4,500 once daily by S/C injection In patients with renal impairment (egfr < 20ml/min), reduce dose of tinzaparin to 3,500 units once daily. Continue tinzaparin until mobility no longer significantly reduced For patients having major cancer surgery in the abdomen and pelvis continue tinzaparin for 28 days in total Major cancer surgery in the abdomen and pelvis o Patients having major cancer surgery in the abdomen and pelvis will receive tinzaparin 4,500 units once daily (if no contra-indications) for 28 days in total after surgery Day Surgery o Offer anti-embolism stockings at admission. If risk of major bleeding low and VTE risk increased, add tinzaparin until mobility no longer significantly reduced (usually 5-7 days) Breast Surgery o In patients having breast surgery, the consultant breast surgeons have requested that a lower dose of tinzaparin 3500 units once daily should be prescribed postoperatively due to the higher risk of haematoma. Use 4500 units once daily in patients over 100kg Recommendations for Major Orthopaedic Surgery For all patients: Maintain hydration Ensure early mobilisation Use correctly fitted TED stockings OR IPC See Appendix 4 Hip Fracture Surgery Patients undergoing hip fracture surgery will receive tinzaparin 4,500 units once daily (if no contra-indications) AND TED Stockings for 28 days.

15 Reduce dose of tinzaparin to 3,500 units once daily if egfr <20ml/min. o Patients will be trained to self-administer the tinzaparin injection during their inpatient stay where possible and will be provided with information packs which discuss self-administration and prevention of DVT s whilst an in-patient. The hospital pharmacy will supply the full course of tinzaparin S/C injection on discharge. o Patients will be monitored for HITS as described in section 6.4 o o WHERE POSSIBLE PRESCRIBE TINZAPARIN AT 6.00pm If tinzaparin is to be given by district nurses upon discharge, prescribers must also complete the district nursing administration chart. Total Hip Replacement Surgery Patients undergoing Total Hip Replacement surgery will receive apixaban (if no contra-indications) 2.5mg twice daily and TEDs for 32 days in total. o Apixaban can be taken orally and does not require any blood monitoring. If apixaban is contra-indicated e.g. egfr < 15ml/min or prescribed an interacting medication (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital see BNF or manufacturers data sheet for full details) an appropriate dose of tinzaparin can be prescribed instead. Total Knee Replacement Surgery Patients undergoing Total Knee Replacement surgery will receive apixaban 2.5mg twice daily (if no contra-indications) and TEDs for 10 days in total. o Apixaban can be taken orally and does not require any blood monitoring. If apixaban is contra-indicated eg egfr < 15ml/min or prescribed an interacting medication (e.g. rifampicin, phenytoin, carbamazepine, Phenobarbital see BNF or manufacturers data sheet for full details) an appropriate dose of tinzaparin can be prescribed instead. However, in patients who are concurrently on drugs that interact with apixiban (as listed in the SPC see section 6.11 apixiban additional information), the patient will be prescribed tinzaparin 4500units once daily post-operatively. Fracture Neck of Femur Enhanced Recovery Patients Patients with a fractured neck of femur and on the enhanced recovery programme will have the first dose of prophylactic tinzaparin prescribed at hours on the evening of surgery and then at 18:00 hours on subsequent days. The first dose of tinzaparin will be prescribed by theatre staff as a stat dose on the patient s drug chart Lower limb plaster casts Patients having lower limb plaster casts should have their VTE risk assessed. If the VTE risk is considered to be increased, consider offering tinzaparin 4,500 units once daily, after evaluating risks and benefits and based on clinical discussion with the patient. Thromboprophylaxis should continue until the plaster cast is removed Apixaban Additional information Apixaban, a direct inhibitor of activated factor X, is an oral anticoagulant licensed for prophylaxis of venous thromboembolism following knee and hip replacement surgery.

16 Apixaban is licensed to be given between hours post-op. Apixaban does not require therapeutic monitoring. The dose of apixiban to be prescribed at 0800 and The first dose should be administered as follows: Time when the wound is closed: Between 08:00 and 20:00 hrs After 20:00 - First dose to be given at 08:00 (next day) - First dose to be given at 18:00 (next day) The common side-effects are nausea and haemorrhage and patients should be monitored for signs of bleeding or anaemia; treatment should be stopped if severe bleeding occurs. Cautions and contra-indications to apixaban treatment include (See SPC for full list): o Clinically significant active bleeding o Hepatic disease associated with coagulopathy and clinically relevant bleeding risk o Pregnancy and lactation o Hypersensitivity to the active substance or to any of the excipients o Use is not recommended in patients with egfr < 15 ml/min o The use of apixaban is not recommended in patients receiving concomitant systemic treatment with strong inhibitors of both CYP3A4 and P-gp, such as azoleantimycotics (e.g., ketoconazole, itraconazole, voriconazole and posaconazole) and HIV protease inhibitors (e.g., ritonavir). The concomitant use of apixaban with strong CYP3A4 and P-gp inducers (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital or St. John's Wort) may lead to a ~50% reduction in apixaban exposure. Concomitant use is not recommended. o.as with other anticoagulants, patients taking apixaban are to be carefully observed for signs of bleeding. It is recommended to be used with caution in conditions with increased risk of haemorrhage, such as: congenital or acquired bleeding disorders; active ulcerative gastrointestinal disease; bacterial endocarditis; thrombocytopenia; platelet disorders; history of haemorrhagic stroke; severe uncontrolled hypertension; and recent brain, spinal, or ophthalmological surgery. A specific antidote antagonising the pharmacodynamic effect of apixaban is not available. The SPC recommends appropriate symptomatic treatment in the event of haemorrhage. If life-threatening bleeding cannot be controlled by symptomatic treatment, administration of recombinant factor VIIa may be considered. Contact the haematology lab or consultant for the most up to date advice. In the event of a patient developing a thromboembolism whilst on apixaban, the patient should be immediately commenced on a treatment dose of tinzaparin as per trust protocol Spinal / Epidural Anaesthesia If epidural / spinal anaesthesia might be used DO NOT GIVE LMWH within 12 hours of surgery. If in doubt, consult an anaesthetist. The anaesthetist should ensure the peri-operative dose is prescribed or given appropriately. Insertion or removal of an epidural catheter should be done 12 hours after administration of tinzaparin prophylaxis (4500 units or less). Patients receiving higher doses will require a longer delay of 24 hours. For patients on apixaban, insertion or removal of an epidural catheter should be done at least 20 hours after apixaban dose and at least one dose of apixaban should be omitted before catheter withdrawal Once an epidural catheter is inserted or removed there should be a delay of at least

17 4 hours before tinzaparin is given. Vigilance and frequent monitoring is needed due to higher risk of spinal haematoma. For patients on apixaban, once an epidural catheter is inserted or removed, there should be a delay of at least 6 hours before apixaban is given Thromboprophylaxis in Medical Patients For all patients: Maintain hydration Ensure early mobilisation Use correctly fitted TED stockings IF APPROPRIATE See appendix 3 If LMWH not contraindicated, use Tinzaparin 4,500 once daily by S/C injection In patients with renal impairment (egfr < 20ml/min), reduce dose of tinzaparin to 3,500 units once daily. Continue tinzaparin until mobility no longer significantly reduced In patients admitted for stroke do not offer anti-embolism stockings. Offer tinzaparin if patient has major restriction of mobility, previous history of VTE, dehydration or co morbidity and haemorrhagic stroke is excluded and risk of bleeding is low Offer tinzaparin to all cancer patients who are at increased risk of VTE unless, ambulatory and solely admitted for chemo or radiotherapy or if a risk of bleeding or contraindication to tinzaparin exists Consider offering tinzaparin to patients with central venous catheters who are at increased risk of VTE and are not ambulant Patients with head injuries should not be offered thromboprophylaxis unless the risk of intracranial bleeding has been excluded seek consultant or specialist advice 7.15 Recommendations in Pregnancy and Post-Partum See Venous Thromboembolism in Pregnancy and Puerperium guidelines on Trust intranet. Patients who are pregnant or post-partum should be risk assessed using the antenatal risk assessment form for an antenatal admission or risk assessment form for labour and postnatally as appropriate see Appendix Pharmacological Treatment of VTE see Appendix 10 and Appendix 11 The drug of choice to treat VTE is tinzaparin. The treatment dose is 175 units/kg once daily Ensure the patient is weighed at the start of therapy and, where applicable, during treatment. The weight should be accurately recorded on the front of the drug chart and in the clinical record Consider renal function when prescribing treatment doses of tinzaparin. If the e-gfr< 30mls/min, then use a treatment dose of enoxaparin see Summary of Product Characteristics (SPC) for enoxaparin for advice on dosage adjustments. The renal function test should not delay treatment but should be checked as soon as possible after initiation of treatment

18 Ensure essential information such as dose, weight, renal function, indication and duration of therapy are communicated to the GP on discharge by ensuring all relevant information is completed in the patient s e-dnf on discharge For patients who are discharged on treatment dose LMWH, ensure that platelets are monitored as appropriate (see section 6.4). The patient s e-dnf should be completed with any monitoring requirements so that the GP is fully informed. If the patient is to commence oral anticoagulation, ensure the patient is counselled fully with regards to anticoagulation therapy. Ensure the yellow anticoagulant book is filled in on patient discharge with the recent INR values and patient s dose of anticoagulant Ensure follow up has been arranged with the anticoagulant clinic or person(s) responsible for monitoring of INR Ensure a referral form has been filled in and forwarded to the anticoagulant clinic if appropriate. Please note that warfarin is the preferred agent for anticoagulation, however rivaroxaban (as per NICE TA 261,287) and apixaban (as per NICE TA 341) is an alternative option for treatment of DVT and PE. Ensure the GP is fully informed with regard to initiation of anticoagulant treatment and follow up arrangements by ensuring all relevant information is completed on the patient s e- DNF on discharge. 8.0 Measuring Performance and Audit Compliance to VTE risk assessment on admission is measured using the national mandated scheme figures submitted monthly through to UNIFY The Trust recognises its responsibility to check practice adherence to Trust policy and compliance to the VTE policy will be monitored as set out in the table below: Process/risk assessment for identifying patients at risk of venous thromboembolism Prophylactic treatment regime for high risk patients Procedure to be followed if Venous Thromboembolism is suspected Management of the patient once a positive diagnosis has been made Organization s expectations in relation to staff training as identified in the training needs analysis The VTE group will monitor the numbers of patients being risk assessed at its monthly meeting and results disseminated to service lines via their SQS groups for action if noncompliance. The use of prophylactic regimes will be audited annually by the service lines and results/action plans disseminated to their SQS and reported to the MMG/ VTE group. Clinical audit of the DVT, PE and Massive PE guidelines will be undertaken annually by the Medical Specialities service line and results/action plans presented to service line speciality audit meeting. Clinical audit of the DVT, PE and Massive PE guidelines will be undertaken annually by the Medical Specialities service line and results/action plans presented to service line SQS /MMG /VTE groups This will be monitored by line managers via mandatory training reports provided by ESR team

19 9.0 Review This policy will be approved and monitored by the Medicines Management Group (MMG) and VTE group and will be reviewed every three years or sooner if required following changes to national guidance, changes required to clinical practice, or following findings from audit References 1. NICE CG92 Jan 2010, Venous Thromboembolism: Reducing the Risk 2. Addendum to Clinical Guideline CG92, June 2015 Venous thromboembolism in adults admitted to hospital: reducing the risk (Chapter 24 stroke patients) 3. NICE CG144, June 2012, Venous Thromboembolic diseases: the management of venous thromboembolic diseases and the role of thrombophilia testing and Evidence Update April NICE medical technology guidance 19 June 2014, The geko device for reducing the risk of venous thromboembolism 5. SIGN Guidelines No 122, Prevention and Management of Venous Thromboembolism Dec February 2012; 141(2_suppl) Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines 7. Royal College of Obstetricians and Gynaecologists Green top Guideline No 37a, Reducing the Risk of Thrombosis and Embolism during Pregnancy and the Puerperium, November Royal College of Obstetricians and Gynaecologists Green top Guideline No 37b, Thrombosis and embolism during pregnancy and the puerperium, the acute management of. Feb SPC Innohep (Leo Pharmaceuticals), March SPC Eliquis (Bristol Myers Squibb-Pfizer), July SPC Clexane (Sanofi-Aventis), Nov NPSA Alert RRR014, 2010, Reducing treatment dose errors with low molecular weight heparins 13. Guidelines on the diagnosis and management of heparin-induced thrombocytopenia: second edition Vol 159 Issue 5 pg British Journal of Haematology 2012

20 Appendix 1 O/A, 24 hour risk assessment and weekly risk assessment forms Name: NHS No: DOB: RISK ASSESSMENT FOR VENOUS THROMBOEMBOLISM (VTE) All patients should be assessed on admission and then within 24 hours of date and time of admission followed by weekly reassessment unless the clinical situation dictates an earlier assessment. For elective surgical patients the risk assessment will be carried out at pre-op clinic-this assessment should be re-checked on admission. Based on DOH National VTE Risk Assessment Tool 2010 and NICE Clinical Guideline 92- Venous Thromboembolism: Reducing the Risk (Jan 2010) STEP ONE: Assess all patients admitted to hospital for level of mobility. All surgical patients and all medical patients with significantly reduced mobility and all medical patients who are mobile but acutely unwell should be considered for further risk assessment STEP TWO: Review patient-related factors on the assessment sheet against thrombosis risk and tick each box that applies. Any tick should prompt thromboprophylaxis according to NICE guidance. The risk factors are not exhaustive STEP THREE: Review the patient-related factors shown against bleeding risk and tick each box that applies. Any tick should prompt clinical staff to consider if bleeding risk is sufficient to preclude pharmacological intervention STEP FOUR: Sign, Date and implement Trust Prevention of VTE Guidelines see guidelines on trust intranet for contraindications and cautions to prescribing tinzaparin. For all patients: Ensure early mobilisation and maintain hydration. All surgical patients to receive anti-embolism stockings OR intermittent pneumatic compression (IPC) unless contraindicated. Medical patients to receive anti-embolism stockings if appropriate. Before prescription of stockings, check for contraindications - see appendix 3 of Trust VTE policy STANDARD PHARMACOLOGICAL VTE PROPHYLAXIS Tinzaparin should be given by subcutaneous injection. Use tinzaparin 4500units daily. Reduce dose to 3500units daily if egfr<20ml/min. For patients weighing less than 50kg, reduce dose of tinzaparin to 2500 units daily. If weight >100kg AND egfr<20ml/min seek advice from consultant haematologist Surgical patients In surgical patients, prescribe tinzaparin where possible at 18:00hrs, a minimum of 6 hours post-operatively, at the discretion of the clinician Total Hip Replacement apixaban 2.5mg twice daily, postoperatively for 32 days in total Total Knee Replacement apixaban 2.5mg twice daily, post-operatively for 10 days in total Hip fracture surgery tinzaparin as above for 28 days in total Major cancer surgery in the abdomen and pelvis tinzaparin as above for 28 days in total Day surgery offer anti-embolism stockings on admission. If risk of major bleeding low and VTE risk increased, add tinzaparin as above until mobility no longer significantly reduced (usually 5-7 days) Patients having lower limb plaster casts and increased risk of VTE, consider offering tinzaparin until cast removed SPINAL/EPIDURAL ANAESTHESIA Medical Patients In patients admitted for stroke do not offer antiembolism stockings. Consider offering tinzaparin if patient has major restriction of mobility, previous history of VTE, dehydration or comorbidity and haemorrhagic stroke is excluded and risk of bleeding is low. Stop tinzaparin when acute event over and patient s condition is stable Offer tinzaparin to all cancer patients who are at increased risk of VTE unless, ambulatory and solely admitted for chemo or radiotherapy or if a risk of bleeding or contraindication to tinzaparin exists Consider offering tinzaparin to patients with central venous catheters who are at increased risk of VTE and are not fully ambulant Patients with head injuries should not be offered thromboprophylaxis unless the risk of intracranial bleeding has been excluded seek consultant advice If epidural / spinal anaesthesia might be used DO NOT GIVE LMWH within 12 hours of surgery. If in doubt, consult an anaesthetist. The anaesthetist should ensure the peri-operative dose is prescribed or given appropriately. Insertion or removal of an epidural catheter should be done 12 hours after administration of tinzaparin prophylaxis (4500 units or less). Patients receiving higher doses will require a longer delay of 24 hours. For patients on apixaban, insertion or removal of an epidural catheter should be done at least 20-30hours after apixaban dose. At least one dose of apixaban should be omitted before catheter withdrawal Once an epidural catheter is inserted or removed there should be a delay of at least 4 hours before tinzaparin is given. Vigilance and frequent monitoring is needed due to higher risk of spinal haematoma. For patients on apixaban, once an epidural catheter is inserted or removed, there should be a delay of at least 6 hours before apixaban is given. If tinzaparin is not to be prescribed cross off pre-printed prescription for LMWH on the drug chart

21 N.B. Column 1: risk assessment on admission, Column 2: Risk Assessment within next 24hrs, Column 3: Week 1 assessment. For further weekly assessments use weekly risk assessment forms STEP ONE: Classify each patient into one of the 3 groups below Surgical patient Medical patient have had or expected to have a reduction of mobility of 3 days or more OR is acutely ill Action Complete sequentially:- STEP TWO, THREE & FOUR Medical patient with normal mobility and without acute illness Go straight to STEP FOUR Note that in pregnancy or <6 weeks post-partum - Use VTE risk assessment forms for an antenatal admission or VTE risk assessment form for labour and postnatally as appropriate. Obstetric VTE risk assessment forms are available on the trust internet in the Trust Prevention of VTE Guidelines. Also see Trust guidance for VTE during pregnancy, labour and postnatally STEP TWO: Thrombosis risk Review the patient and tick every box that applies. Patient related 1 O/A 2 24hrs 3 Wk Admission related 1 O/A 2 24hrs 3 Wk Significantly reduced mobility for 3 days or more Active cancer or cancer treatment Age > 60 Dehydration Known thrombophilias Obesity (BMI > 30kg/m 2 ) One or more significant medical co-morbidities (eg heart disease; metabolic, endocrine, or respiratory pathologies; acute infectious diseases; inflammatory conditions) Personal history or first degree relative with a history of VTE Use of hormone replacement therapy Hip or Knee replacement Hip fracture Total anaesthetic + surgical time > 90 minutes Surgery involving pelvis or lower limb with a total anaesthetic + surgical time > 60 minutes Acute Surgical admission with inflammatory or intra-abdominal condition Critical Care admission Surgery with significant reduction in mobility Use of oestrogen containing contraceptive therapy Varicose veins with phlebitis STEP THREE: Bleeding risk Review the patient and tick every box that applies. Patient related Admission related Active bleeding or suspicion of bleeding Acquired bleeding disorders (such as liver failure) Concurrent use of anticoagulants known to increase the risk of bleeding (such as warfarin with INR > 2) Acute stroke Neurosurgery, spinal surgery or eye surgery Other procedure with high bleeding risk Lumbar puncture/epidura/spinal anaesthesia expected within the next 12 hrs Lumbar puncture / epidural / spinal anaesthesia within the previous 4 hours Thrombocytopenia (platelets < 75 x 10 9 /l ) Uncontrolled systolic hypertension ( 230/120 mmhg or higher) Patients being clinically managed for DVT, PE or Acute Coronary Syndrome and on fondaparinux or tinzaparin do not require thromboprophylaxis Untreated inherited bleeding disorders (such as haemophilia and Von Willebrand s disease) STEP FOUR: Assess risks vs benefits of prescribing thromboprophylaxis and then sign, date and implement Trust s Thromboprophylaxis Guideline. Prescribe all medication in prescription chart. Date and time of completion: Date and time of completion: On admission Assessment completed by (name and signature) 24 hour Assessment completed by (name and signature) For elective surgical patients only: Pre-op assessment completed by (name and signature) Date and time of completion: First Weekly Assessment completed by (name and signature) Date of completion: O/A 24 hrs Week 1 Thromboprophylaxis to be prescribed Yes / No Yes / No Yes / No Antiembolic stockings required Yes / No Yes / No Yes / No Reason thromboprophylaxis not prescribed.. Any contraindications for antiembolic stockings...

22 N.B. Column 1, Column 2 and Column 3 for separate weekly assessments. For further weekly assessments use additional weekly risk assessment forms STEP ONE: Classify each patient into one of the 3 groups below RISK ASSESSMENT FOR VENOUS THROMBOEMBOLISM (VTE) All patients should be assessed on admission and then within 24 hours of date and time of admission followed by weekly reassessment unless the clinical situation dictates an earlier assessment. Based on DOH National VTE Risk Assessment Tool 2010 and NICE Clinical Guideline 92- Venous Thromboembolism: Reducing the Risk (Jan 2010) STEP ONE: Assess all patients admitted to hospital for level of mobility. All surgical patients and all medical patients with significantly reduced mobility and all medical patients who are mobile but acutely unwell should be considered for further risk assessment STEP TWO: Review patient-related factors on the assessment sheet against thrombosis risk and tick each box that applies. Any tick should prompt thromboprophylaxis according to NICE guidance. The risk factors are not exhaustive STEP THREE: Review the patient-related factors shown against bleeding risk and tick each box that applies. Any tick should prompt clinical staff to consider if bleeding risk is sufficient to preclude pharmacological intervention STEP FOUR: Sign, Date and implement Trust Prevention of VTE Guideline see guidelines on trust intranet for contraindications and cautions to prescribing tinzaparin. For all patients: Ensure early mobilisation and maintain hydration. All surgical patients to receive anti-embolism stockings OR intermittent pneumatic compression (IPC) unless contraindicated. Medical patients to receive anti-embolism stockings if appropriate. STANDARD PHARMACOLOGICAL VTE PROPHYLAXIS Tinzaparin should be given by subcutaneous injection. Use tinzaparin 4500units daily. Reduce dose to 3500units daily if egfr<20ml/min. For patients weighing less than 50kg, reduce dose of tinzaparin to 2500 units daily. If weight >100kg AND egfr<20ml/min seek advice from consultant haematologist Surgical patients In surgical patients, prescribe tinzaparin where possible at 18:00, a minimum of 6 hours post operatively, at the discretion of the clinician Total Hip Replacement apixaban 2.5mg twice daily, post-operatively for 32 days in total Total Knee Replacement apixaban 2.5mg twice daily, post-operatively for 10 days in total Hip fracture surgery tinzaparin as above for 28 days in total Major cancer surgery in the abdomen and pelvis tinzaparin as above for 28 days in total Day surgery offer anti-embolism stockings on admission. If risk of major bleeding low and VTE risk increased, add tinzaparin as above until mobility no longer significantly reduced (usually 5-7 days) Patients having lower limb plaster casts and increased risk of VTE, consider offering tinzaparin until cast removed Medical Patients In patients admitted for stroke do not offer antiembolism stockings. Consider offering tinzaparin if patient has major restriction of mobility, previous history of VTE, dehydration or comorbidity and haemorrhagic stroke is excluded and risk of bleeding is low. Stop tinzaparin when acute event over and patient s condition is stable Offer tinzaparin to all cancer patients who are at increased risk of VTE unless, ambulatory and solely admitted for chemo or radiotherapy or if a risk of bleeding or contraindication to tinzaparin exists Consider offering tinzaparin to patients with central venous catheters who are at increased risk of VTE and are not fully ambulant Patients with head injuries should not be offered thromboprophylaxis unless the risk of intracranial bleeding has been excluded -seek consultant advice SPINAL/EPIDURAL ANAESTHESIA If epidural / spinal anaesthesia might be used DO NOT GIVE LMWH within 12 hours of surgery. If in doubt, consult an anaesthetist. The anaesthetist should ensure the peri-operative dose is prescribed or given appropriately. Insertion or removal of an epidural catheter should be done 12 hours after administration of tinzaparin prophylaxis (4500 units or less). Patients receiving higher doses will require a longer delay of 24 hours. For patients on apixaban, insertion or removal of an epidural catheter should be done at least hours after apixaban dose. At least one dose of apixaban should be omitted before catheter withdrawal. Once an epidural catheter is inserted or removed there should be a delay of at least 4 hours before tinzaparin is given. Vigilance and frequent monitoring is needed due to higher risk of spinal haematoma. For patients on apixaban, once an epidural catheter is inserted or removed, there should be a delay of at least 6 hours before apixaban is given. If tinzaparin is not to be prescribed cross off pre-printed prescription for LMWH on the drug chart.

23 Surgical patient Medical patient have had or expected to have a reduction of mobility of 3 days or more OR is acutely ill Action Complete sequentially:- STEP TWO, THREE & FOUR Medical patient with normal mobility and without acute illness Go straight to STEP FOUR Note that in pregnancy or <6 weeks post-partum - Use VTE risk assessment forms for an antenatal admission or VTE risk assessment form for labour and postnatally as appropriate. Obstetric VTE risk assessment forms are available on the trust internet in the Trust Prevention of VTE Guidelines. Also see Trust guidance for VTE during pregnancy, labour and postnatally STEP TWO: Thrombosis risk Review the patient and tick every box that applies Patient related 1 Wk Active cancer or cancer treatment 2 Wk 3 Wk Admission related 1 Wk Significantly reduced mobility for 3 days or more 2 Wk 3 Wk Age > 60 Hip or Knee replacement Dehydration Hip fracture Known thrombophilias Total anaesthetic + surgical time > 90 minutes Obesity (BMI > 30kg/m2) Surgery involving pelvis or lower limb with a total anaesthetic + surgical time > 60 minutes One or more significant medical co-morbidities (eg heart disease; metabolic, endocrine, or respiratory pathologies; acute infectious diseases; inflammatory conditions) Acute Surgical admission with inflammatory or intra-abdominal condition Personal history or first degree relative with a history of VTE Critical Care admission Use of hormone replacement therapy Surgery with significant reduction in mobility Use of oestrogen containing contraceptive therapy Varicose veins with phlebitis STEP THREE: Bleeding risk Review the patient and tick every box that applies. Patient related Admission related Active bleeding or suspicion of bleeding Acquired bleeding disorders (such as liver failure) Concurrent use of anticoagulants known to increase the risk of bleeding (such as warfarin with INR > 2) Acute stroke Thrombocytopenia (platelets < 75 x 10 9 /l ) Neurosurgery, spinal surgery or eye surgery Other procedure with high bleeding risk Lumbar puncture/epidura/spinal anaesthesia expected within the next 12 hrs Lumbar puncture / epidural / spinal anaesthesia within the previous 4 hours Uncontrolled systolic hypertension ( 230/120 mmhg or higher) Untreated inherited bleeding disorders (such as haemophilia and Von Willebrand s disease) NB Patients being clinically managed for DVT, PE or Acute Coronary Syndrome and on fondaparinux or tinzaparin do not require thromboprophylaxis STEP FOUR: Assess the risks vs benefits of prescribing thromboprophylaxis and then sign, date and implement Trust s Thromboprophylaxis Guideline. Prescribe all medication in prescription chart. Date and time of completion: Week. Assessment completed by (name and signature) Date and time of completion: Week.. Assessment completed by (name and signature) Date and time of completion: Week.. Assessment completed by (name and signature) Week 1 Week 2 Week 3 Thromboprophylaxis to be prescribed Yes / No Yes / No Yes / No Antiembolic stockings required Yes /No Yes / No Yes / No Reason thromboprophylaxis not prescribed..... Any contraindication for antiembolic stockings Yes/No

24 Appendix 2 Peri-operative anticoagulation for patients admitted on anticoagulation undergoing elective surgery Pre-op target INR <1.5 Or Surgeon / Anaesthetist discretion (check for specialist/specific instructions in notes) For reversal of INR with vitamin K peri-operatively see VTE policy Low Risk Patient Stop oral anticoagulation 5 days before surgery i.e. omit 5 doses High Risk Patient Stop oral anticoagulation 5 days before surgery i.e. omit 5 doses Commence Tinzaparin175iu/kg each morning 5 days prior to surgery Morning of surgery check INR Thromboprophylaxis should be initiated Omit therapeutic dose of Tinzaparin according to Policy and continued until oral anticoagulation is within therapeutic range (INR >2) Evening of surgery Evening of surgery Administer prophylactic dose of Tinzaparin 6 hours post -op Restart oral anticoagulation at 1.5 x normal dose for first 2 days Unless: patient is NBM, has epidural or at Surgeon/ Anaesthetist discretion Day following surgery restart therapeutic dose of Tinzaparin and continue until INR within therapeutic range (INR >2) Check INR on day 3 Check INR on day 3 If INR less than or within therapeutic range If INR within therapeutic range recommence normal anticoagulant dose recommence normal anticoagulant dose If INR above therapeutic range seek advice If INR above or below therapeutic range seek advice Arrange earliest anticoagulant clinic appointment on discharge Clot Low Risk Clot High Risk e.g. atrial fibrillation (AF) Prosthetic (mechanical) heart valve with CHA 2 DS 2 VASc score <6 (see page 2) All DVT/PE on anticoagulation AF with CHA s DS 2 VASc score equal > 6 NB ENSURE YELLOW ANTI-CAOGULANT RECORD BOOK IS UPDATED If in doubt seek advice Consultant Haematologist Dr John Hudson ex or switchboard Pharmacy Medicines Information ex 1268 or 3835 Anticoagulation Policy Working Party: Dr J Hudson - Consultant Haematologist Dr M Rothwell - Consultant Anaesthetist Mr P Denn - Associate Specialist Orthopaedics Mr K R Ratnam - Associate Specialist Orthopaedics Dr R Egdell - Consultant Cardiologist Mrs P Rowan - Peri-operative Specialist Practitioner Ms C Lloyd - Peri-operative Specialist Practitioner Mrs A Littlewood - Medicines Management Pharmacist Mrs J Razzaq-Sheikh - Lead SBU Pharmacist NB The Pre-operative assessment team will assess elective surgical and elective surgical ETU patients on oral anticoagulation using the guideline and arrange for prescriptions of therapeutic Tinzaparin to be prescribed by the Consultant team for that patient. A total of 10 therapeutic injections will be supplied by the Hospital pharmacy. 15 therapeutic injections will be supplied to the patients who have a mechanical heart valve.

25 CHA 2 DS 2 VASc SCORE AND STROKE RATE CHA 2 DS 2 VASc score is a clinical prediction rule for estimating the risk of stroke in patients with atrial fibrillation. A high CHA 2 DS 2 VASc score corresponds to a greater risk of stroke, while a low CHA 2 DS 2 VASc score corresponds to a lower risk of stroke. Risk Factor Score Congestive heart failure/lv dysfunction 1 Hypertension 1 Age> or equal to 75 2 Diabetes mellitus 1 Stroke/TIA/thrombo-embolism 2 Vascular disease a 1 Age Sex category (ie female sex) 1 Maximum Score 9 a: Prior myocardial infarction, peripheral artery disease, aortic plaque. A patient with AF and a CHA 2 DS 2 VASc score 6should follow the high risk arm of the policy for the peri-operative management of patients admitted on anticoagulation. Patients with AF and CHA 2 DS 2 VASc score < 6 should follow the low risk arm. Adjusted stroke rate according to CHA 2 DS 2 VASc score: CHA 2 DS 2 VASc Patients (n=7329) Adjusted stroke rate (%/year) score 0 1 0% % % % % % % % % % Adapted from European Society of Cardiologists Clinical Practice Guidelines Atrial Fibrillation (Management of) 2010 and Focused Update (2012)

26 Peri-operative anticoagulation guidelines for elective surgical patients on anticoagulation treatment Flow Chart for managing cancelled elective surgical patients on anticoagulant treatment Patient cancelled on day BEFORE OR ON DAY OF surgery Bed Manager informs Surgical /Orthopaedic Ward Band 7 /Band 6 In the absence of the Band 7/6 this will be the senior nurse on duty Band 7 /Band 6/Senior Nurse informs Surgical team and patient records obtained SURGICAL TEAM CHECK PATIENTS RECORDS TO CONFIRM LOW OR HIGH RISK STATUS IMPLEMENT INSTRUCTIONS BELOW FOR CANCELLATION ON DAY BEFORE SURGERY OR DAY OF SURGERY LOW RISK Contact patient and advise to recommence Warfarin at 1.5 times usual dose on day of cancellation for 2 days then continue with usual dose HIGH RISK Prescribe 7 days of therapeutic Tinzaparin 175iu/Kg (see patient records for last prescription) and complete District Nurse prescription sheet if required Ensure prescription is obtained prior to pharmacy closing Contact patient/carer to collect prescription and advise to recommence Warfarin at 1.5 times usual dose on day of cancellation for 2 days then continue with usual dose Band 7 /Band 6/Senior Nurse to arrange District Nurse for patients who do not self-administer Tinzaparin injections Arrange anticoagulant appointment within the following week Arrange anticoagulant appointment within the following week

27 Perioperative Management of Patients on Anticoagulant Therapy who Require Urgent Surgery For urgent reversal of INR in patients requiring immediate surgery eg trauma patients, give 10mg of Vitamin K injection intravenously with Fresh Frozen Plasma (FFP). For more immediate reversal of the anticoagulant effect consideraton should be given to the use of Prothrombin Complex Concentrate (PCC) and Vitamin K. Please discuss with oncall haematologist. In less urgent instances (for example patients having elective surgery and whose INR is still high (>1.5) despite having their anticoagulant therapy withheld) give 2mg Vitamin K injection by the oral route. Konakion MM Paediatric is licensed for administration by the oral route.

28 Appendix 3 GUIDELINES FOR USE OF GRADUATED COMPRESSION STOCKINGS 1. Check for contra-indications to use a. Suspected or proven peripheral arterial disease b. Peripheral arterial bypass grafting c. Peripheral neuropathy or other causes of sensory impairment d. Local condition in which stockings may cause damage, such as fragile tissue paper skin, dermatitis, gangrene or recent skin graft e. Known allergy to material of manufacture f. Cardiac failure g. Severe leg oedema or pulmonary oedema from congestive failure h. Unusual leg size or shape i. Major limb deformity preventing correct fit j. Latex allergy (check product materials to see if latex used) k. Stroke Use caution and clinical judgement when applying anti-embolism stockings over venous ulcers or wounds 2. Explain to the patient the use of the stocking and ensure they understand that this will reduce the incidence of VTE 3. Measure both of the patient s legs, thigh, calf and leg length. If possible the patient should be standing. It is possible that each leg will require different size of stocking. Check the manufacturers chart to obtain the correct type and size of stocking. Record the size in the nurse notes. Staff who fit stockings should be trained in their use and should show patients how to use them 4. If oedema or postoperative swelling develops, ensure legs are re-measured and stockings refitted 5. If arterial disease suspected, seek expert opinion before fitting stockings 6. Use stockings that provide graduated compression and produce a calf pressure of mmhg 7. The stockings should be worn for 23.5 hours each day. They may be removed for 30 minutes to allow the legs to be washed and the patient s skin to be inspected. If patient has significant reduction in mobility, poor skin integrity or sensory loss, inspect skin 2 or 3 times per day, particularly over heels and bony prominences 8. Avoid the use of talcum powder. Avoid the use of creams unless really necessary and ensure the creams are completely absorbed before the stockings are reapplied. 9. Discontinue use of stockings if there is marking, blistering or discolouration of skin, particularly over heels and bony prominences, or if patient has pain or discomfort. If suitable, offer intermittent pneumatic compression as alternative 10. The stockings should be washed in a washing machine and dried in a warm (not hot) tumble drier. The stockings can be sent home for washing. The band at the top of the stockings can be marked with the laundry marker each time they are washed. They should be discarded immediately if blood stained, or after 10 washes. 11. The stockings should be worn during surgery unless they will be in the way of the surgeon.

29 12. Encourage patients to wear the stockings day and night from admission until they no longer have significantly reduced mobility 13. Patient compliance is important. If the stockings are not or cannot be worn correctly they should not be used at all. 14. Record actions clearly in the nursing notes. INTERMITTENT PNEUMATIC COMPRESSION DEVICES 1. Do not offer these devices to patients with a known allergy to the material of manufacture 2. Consider IPC for VTE prophylaxis in immobile patients who are admitted within 3 days of acute stroke. Explain to the patient or their family members or carers (as appropriate) that: a. it reduces the risk of DVT and may provide an increase in survival b. it will not help them recover from stroke, and there may be an associated increased risk of surviving with severe disability. When using intermittent pneumatic compression for patients who are admitted for stroke, provide it for 30 days or until the patient is mobile or discharged, whichever is sooner. [NICE CG 92 update June 2015] 3. Encourage patients on the wards who have these devices to use them for as much of the time as is possible and practical, both when in bed and when sitting in a chair

30 Addressograph Appendix 4 Obstetric Risk Assessment Forms Name: Date of birth: Hospital No: NHS No: Consultant: RISK ASSESSSMENT FOR VENOUS THROMBOEMBOLISM (VTE) IN PREGNANCY AT BOOKING Date of booking: Risk assessment at booking by:.. Signature:... Designation:... Date: Time...BMI:.. Prophylactic dose of Tinzaparin Weight<50kg = 3500 units once daily Weight 50-90kg = 4500 units once daily Weight kg = 7000 units once daily (may be given in 2 divided doses) Weight kg = 9000 units once daily (may be given in 2 divided doses) W eight>170kg = 75 units/kg/day ( may be given as a twice daily dose) In patients with an egfr <20mls/min, seek consultant advice with regard to dosing as a dosage reduction may be required. For contra-indications to tinzaparin see SPC and Prevention of VTE trust guidelines on the intranet. Epidural/Spinal Analgesia: Placement or removal of catheter should be delayed for 12 hrs after administration of prophylactic dose or 24 hrs if higher dose of tinzaparin is used. Tinzaparin should not be given sooner than 4 hrs after catheter removal. NB Women on oral anticoagulants pre-pregnancy should commence treatment dose tinzaparin antenatally seek consultant advice with regard to monitoring and management Antenatal assessment and management (to be assessed at booking and repeated if admitted) Obstetric thromboprophylaxis risk assessment and management Single previous VTE+ Thrombophilia or family history Unprovoked/oestrogen related Previous recurrent VTE (> 1) Single previous VTE with no family history or thrombophilia Thrombophilia + no VTE MEDICAL COMORBIDITIES, e.g. heart or lung disease, SLE, cancer, inflammatory conditions, nephrotic syndrome, sickle cell disease, intravenous drug user. Surgical procedure High risk Require antenatal prophylaxis with Tinzaparin Refer to Consultant Obstetrician Intermediate risk Consider antenatal prophylaxis with Tinzaparin Refer to Middle Grade/ Speciality Dr Age > 35 years Obesity (BMI > 30kg/m 2 ) Parity > 3 Smoker Gross varicose veins Current systemic infection Immobility, e.g. paraplegia, SPD, longdistance travel Pre-eclampsia Dehydration/hyperemesis/OHSS Multiple pregnancy or ART Total (number of Ticks) 3 or more risk factors 2 or more if admitted < 3 risk factors Lower risk Mobilisation and avoidance of dehydration ALL WOMEN SHOULD RECEIVE ADEQUATE HYDRATION AND BE ENCOURAGED TO MOBILISE. Key ART = assisted reproductive therapy, BMI = body mass index (based on booking weight), gross varicose veins = symptomatic, above the knee or associated with phlebitis/oedema/skin changes, immobility = > 3 days, LMWH = lowmolecular-weight heparin, OHSS = ovarian hyperstimulation syndrome, PPH = postpartum haemorrhage, SLE = systemic lupus erythematosus, SPD = symphysis pubis dysfunction with reduced mobility, thrombophilia = inherited or acquired, long-distance travel = > 4 hours, VTE = venous thromboembolism. Lead professional (Cons/Team Leader)

31 Addressograph ANTE NATAL ADMISSION RISK ASSESSMENT FOR VENOUS THROMBOEMBOLISM (VTE) IN PREGNANCY Date of admission:. Risk assessment on admission by: Signature: Designation: Date: Time. Risk assessment at 24 hours by : Signature:. Designation:. Date: Time Prophylactic dose of Tinzaparin Weight<50kg = 3500 units once daily Weight 50-90kg = 4500 units once daily Weight kg = 7000 units once daily (may be given in 2 divided doses) Weight kg = 9000 units once daily (may be given in 2 divided doses) Weight>170kg = 75 units/kg/day may be given as a twice daily dose. In patients with an egfr <20mls/min, seek consultant advice with regard to dosing as a dosage reduction may be required For contra-indications to tinzaparin see SPC and Prevention of VTE trust guidelines on the intranet. Epidural/Spinal Analgesia: Placement or removal of catheter should be delayed for 12 hrs after administration of prophylactic dose or 24 hrs if higher dose of tinzaparin is used. Tinzaparin should not be given sooner than 4 hrs after catheter removal. NB Women on oral anticoagulants pre-pregnancy should commence treatment dose tinzaparin antenatally seek consultant advice with regard to monitoring and management Antenatal assessment and management (to be assessed at booking and repeated if admitted) Obstetric thromboprophylaxis risk assessment and management Admission assessment tick box 1 24 hour assessment tick box 2 Single previous VTE+ Thrombophilia or family history Unprovoked/oestrogen related Previous recurrent VTE (> 1) Single previous VTE with no family history or thrombophilia Thrombophilia + no VTE MEDICAL COMORBIDITIES, e.g. heart or lung disease, SLE, cancer, inflammatory conditions, nephrotic syndrome, sickle cell disease, intravenous drug user. Surgical procedure High risk Require antenatal prophylaxis with Tinzaparin Refer to Consultant Obstetrician Intermediate risk Consider antenatal prophylaxis with Tinzaparin Refer to Middle Grade/ Speciality Dr Age > 35 years Obesity (BMI > 30kg/m 2 ) Parity > 3 Smoker Gross varicose veins Current systemic infection Immobility, e.g. paraplegia, SPD, longdistance travel Pre-eclampsia Dehydration/hyperemesis/OHSS Multiple pregnancy or ART Total (number of Ticks) or more risk factors 2 or more if admitted < 3 risk factors Lower risk Mobilisation and avoidance of dehydration ALL WOMEN SHOULD RECEIVE ADEQUATE HYDRATION AND BE ENCOURAGED TO MOBILISE. Key ART = assisted reproductive therapy, BMI = body mass index (based on booking weight), gross varicose veins = symptomatic, above the knee or associated with phlebitis/oedema/skin changes, immobility = > 3 days, LMWH = lowmolecular-weight heparin, OHSS = ovarian hyperstimulation syndrome, PPH = postpartum haemorrhage, SLE = systemic lupus erythematosus, SPD = symphysis pubis dysfunction with reduced mobility, thrombophilia = inherited or acquired, long-distance travel = > 4 hours, VTE = venous thromboembolism. Lead professional (Cons/Team Leader)

32 Addressograph LABOUR AND POST DELIVERY RISK ASSESSMENT FOR VENOUS THROMBOEMBOLISM (VTE) Prophylactic dose of Tinzaparin Weight<50kg = 3500 units once daily Weight 50-90kg = 4500 units once daily Weight kg = 7000 units once daily (may be given in 2 divided doses) Weight kg = 9000 units once daily (may be given in 2 divided doses) Weight>170kg = 75 units/kg/day may be given as a twice daily dose. In patients with an egfr <20mls/min, seek consultant advice with regard to dosing as a dosage reduction may be required. For contra-indications to tinzaparin see SPC and Prevention of VTE trust guidelines on the intranet. Epidural/Spinal Analgesia: Placement or removal of catheter should be delayed for 12 hrs after administration of prophylactic dose or 24 hrs if higher dose of tinzaparin is used. Tinzaparin should not be given sooner than 4 hrs after catheter removal. NB Women on treatment dose tinzaparin during pregnancy seek consultant advice with regard to post natal management Risk assessment in labour Risk assessment by: Signature: Designation: Date: Time... Risk assessment Post Delivery Risk assessment by: Signature: Designation: Date:. Time. Postnatal assessment and management (to be assessed on delivery suite) Obstetric thrombophrophylaxis risk assessment and management Risk assessment in labour Tick box 1 Risk assessment post-delivery Tick box 2 Any previous VTE+ Anyone requiring antenatal LMWH Caesarean section in labour Asymptomatic thrombophilia (inherited or acquired) BMI > 40kg/m 2 Prolonged hospital admission MEDICAL COMORBIDITIES, e.g. heart or lung disease, SLE, cancer, inflammatory conditions, nephritic syndrome, sickle cell disease, intravenous drug user. Age > 35 years Obesity (BMI > 30kg/m 2 ) Parity > 3 Smoker Elective caesarean section Any surgical procedure in the puerrperium Gross varicose veins Current systemic infection Immobility, e.g. paraplegia, SPD, long-distance travel Pre-eclampsia Mid-cavity rotational operative delivery Prolonged labour (>24 hours) PPH > 1 litre or blood transfusion Total (number of Ticks) High risk At least 6 weeks postnatal prophylactic Tinzaparin Refer to Consultant Obstetrician Intermediate risk At least 7 days postnatal prophylactic Tinzaparin & TED stockings Refer to Refer to Middle Grade/ Speciality Dr Note: if persisting or > 3 risk factors, consider extending thromboprophylaxis with Tinzaparin upto a max of 6 weeks 2 or more risk factors < 2 risk factors Lower risk Mobilisation and avoidance of dehydration ALL WOMEN SHOULD RECEIVE ADEQUATE HYDRATION AND SHOULD BE ENCOURAGED TO MOBILISE. Lead professional (Cons/Team Leader)

33 Addressograph WEEKLY ANTE NATAL ADMISSION RISK ASSESSMENT FOR VENOUS THROMBOEMBOLISM (VTE) IN PREGNANCY Risk assessment weekly from admission Risk assessment by: Signature: Designation: Date: Time Risk assessment weekly from admission Risk assessment by: Signature: Designation: Date:..Time Prophylactic dose of Tinzaparin Weight<50kg = 3500 units once daily Weight 50-90kg = 4500 units once daily Weight kg = 7000 units once daily (may be given in 2 divided doses) Weight kg = 9000 units once daily (may be given in 2 divided doses) Weight>170kg = 75 units/kg/day may be given as a twice daily dose. In patients with an egfr <20mls/min, seek consultant advice with regard to dosing as a dosage reduction may be required For contra-indications to tinzaparin see SPC and Prevention of VTE trust guidelines on the intranet. Epidural/Spinal Analgesia: Placement or removal of catheter should be delayed for 12 hrs after administration of prophylactic dose or 24 hrs if higher dose of tinzaparin is used. Tinzaparin should not be given sooner than 4 hrs after catheter removal. NB Women on oral anticoagulants pre-pregnancy should commence treatment dose tinzaparin antenatally seek consultant advice with regard to monitoring and management Weekly Antenatal assessment and management / Develops other intercurrent problems during antenatal period Obstetric thromboprophylaxis risk assessment and management Weekly assessment tick box Single previous VTE+ Thrombophilia or family history Unprovoked/oestrogen related Previous recurrent VTE (> 1) Single previous VTE with no family history or thrombophilia Thrombophilia + no VTE MEDICAL COMORBIDITIES, e.g. heart or lung disease, SLE, cancer, inflammatory conditions, nephrotic syndrome, sickle cell disease, intravenous drug user. Surgical procedure High risk Require antenatal prophylaxis with Tinzaparin Refer to Consultant Obstetrician Intermediate risk Consider antenatal prophylaxis with Tinzaparin Refer to Middle Grade/ Speciality Dr Age > 35 years Obesity (BMI > 30kg/m 2 ) Parity > 3 Smoker Gross varicose veins Current systemic infection Immobility, e.g. paraplegia, SPD, longdistance travel Pre-eclampsia Dehydration/hyperemesis/OHSS Multiple pregnancy or ART Total (number of Ticks) or more risk factors 2 or more if admitted < 3 risk factors Lower risk Mobilisation and avoidance of dehydration ALL WOMEN SHOULD RECEIVE ADEQUATE HYDRATION AND BE ENCOURAGED TO MOBILISE. Key ART = assisted reproductive therapy, BMI = body mass index (based on booking weight), gross varicose veins = symptomatic, above the knee or associated with phlebitis/oedema/skin changes, immobility = > 3 days, LMWH = low-molecular-weight heparin, OHSS = ovarian hyperstimulation syndrome, PPH = postpartum haemorrhage, SLE = systemic lupus erythematosus, SPD = symphysis pubis dysfunction with reduced mobility, thrombophilia = inherited or acquired, long-distance travel = > 4 hours, VTE = venous thromboembolism. Lead professional (Cons/Team Leader)

34 Addressograph WEEKLY POST DELIVERY RISK ASSESSMENT FOR VENOUS THROMBOEMBOLISM (VTE) Prophylactic dose of Tinzaparin Weight<50kg = 3500 units once daily Weight 50-90kg = 4500 units once daily Weight kg = 7000 units once daily (may be given in 2 divided doses) Weight kg = 9000 units once daily (may be given in 2 divided doses) Weight>170kg = 75 units/kg/day may be given as a twice daily dose. In patients with an egfr <20mls/min, seek consultant advice with regard to dosing as a dosage reduction may be required. For contra-indications to tinzaparin see SPC and Prevention of VTE trust guidelines on the intranet. Epidural/Spinal Analgesia: Placement or removal of catheter should be delayed for 12 hrs after administration of prophylactic dose or 24 hrs if higher dose of tinzaparin is used. Tinzaparin should not be given sooner than 4 hrs after catheter removal. NB Women on treatment dose tinzaparin during pregnancy seek consultant advice with regard to post natal management Weekly Postnatal assessment and management Obstetric thrombophrophylaxis risk assessment and management Risk assessment weekly from admission Risk assessment by: Signature: Designation: Date:.. Time. Second week from admission Risk assessment by: Signature: Designation: Date:..Time. Risk assessment week 1Tick box 1 Risk assessment week 2 Tick box 2 Use a new form if admitted longer than 2 weeks Any previous VTE+ Anyone requiring antenatal LMWH Caesarean section in labour Asymptomatic thrombophilia (inherited or acquired) BMI > 40kg/m 2 Prolonged hospital admission MEDICAL COMORBIDITIES, e.g. heart or lung disease, SLE, cancer, inflammatory conditions, nephritic syndrome, sickle cell disease, intravenous drug user High risk At least 6 weeks postnatal prophylactic Tinzaparin Refer to Consultant Obstetrician Intermediate risk At least 7 days postnatal prophylactic Tinzaparin & TED stockings Refer to Refer to Middle Grade/ Speciality Dr Note: if persisting or > 3 risk factors, consider extending thromboprophylaxis with Tinzaparin upto a max of 6 weeks Age > 35 years Obesity (BMI > 30kg/m 2 ) Parity > 3 Smoker Elective caesarean section Any surgical procedure in the puerrperium Gross varicose veins Current systemic infection Immobility, e.g. paraplegia, SPD, long-distance travel Pre-eclampsia Mid-cavity rotational operative delivery Prolonged labour (>24 hours) PPH > 1 litre or blood transfusion Total (number of Ticks) or more risk factors < 2 risk factors Lower risk Mobilisation and avoidance of dehydration ALL WOMEN SHOULD RECEIVE ADEQUATE HYDRATION AND SHOULD BE ENCOURAGED TO MOBILISE.

35 Appendix 5 Guidance for stopping and starting New Oral Anticoagulants (NOAC s) in the perioperative period The advice from the manufacturers in relation to stopping NOAC s in the peri-operative period is as follows (reference: accessed on ): Rivaroxaban If an invasive procedure or surgical intervention is required, rivaroxaban should be stopped at least 24 hours before the intervention, if possible, and based on the clinical judgement of the physician. Rivaroxaban should be restarted after the invasive procedure or surgical intervention as soon as possible provided the clinical situation allows and adequate haemostasis has been established as determined by the treating physician Apixiban Apixiban should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of bleeding. This includes interventions for which the probability of clinically significant bleeding cannot be excluded or for which the risk of bleeding would be unacceptable. Apixiban should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding. This includes interventions for which any bleeding that occurs is expected to be minimal, non-critical in its location or easily controlled. If surgery or invasive procedures cannot be delayed, appropriate caution should be exercised, taking into consideration an increased risk of bleeding. This risk of bleeding should be weighed against the urgency of intervention. Apixaban should be restarted after the invasive procedure or surgical intervention as soon as possible provided the clinical situation allows and adequate haemostasis has been established. Dabigatran Patients on dabigatran who undergo surgery or invasive procedures are at increased risk for bleeding. Therefore surgical interventions may require the temporary discontinuation of dabigatran. Caution should be exercised when treatment is temporarily discontinued for interventions and anticoagulant monitoring is warranted. Clearance of dabigatran in patients with renal insufficiency may take longer. This should be considered in advance of any procedures. In such cases a coagulation test may help to determine whether haemostasis is still impaired. Preoperative phase Table 3 summarises discontinuation rules before invasive or surgical procedures. Renal function Estimated half-life Stop dabigatran before elective surgery (CrCL in ml/min) (hours) High risk of bleeding or major surgery Standard risk

36 80 ~ 13 2 days before 24 hours before 50-< 80 ~ days before 1-2 days before 30-< 50 ~ 18 4 days before 2-3 days before (> 48 hours) In summary: Rivoroxaban Patient can be advised to stop the rivoroxaban day before surgery ie at least 24 hours before the intervention) Low risk patients - Day of surgery, receive prophylactic dose of tinzaparin 6 hours post-op. Continue routine thromboprophylaxis until rivoroxaban restarted 3-4days after surgery (or at discretion of surgeon/anaesthetist). High risk patients Day of surgery, receive prophylactic dose of tinzaparin 6 hours post-op. Day after surgery, start therapeutic tinzaparin and discontinue when NOAC restarted. Apixiban Patient can be advised to stop the apixiban 48 hours before elective surgery with high risk of bleeding and 24 hours before surgery with low risk of bleeding. Low risk patient If apixiban stopped 48 hours pre-op, no need for therapeutic tinzaparin pre-op. Day of surgery, receive prophylactic dose of tinzaparin 6 hours post-op. Continue routine thromboprophylaxis until apixiban restarted 3-4days after surgery (or at discretion of surgeon/anaesthetist) High risk patient If apixiban stopped 48 hours pre-op, patient should receive 1 day of therapeutic tinzaparin day before surgery. Day of surgery, receive prophylactic dose of tinzaparin 6 hours post-op and restart apixiban 3-4days after surgery (or at discretion of surgeon/anaesthetist). Start therapeutic tinzaparin on the day after surgery and discontinue when NOAC restarted. Dabigatran Patients may be advised to stop the dabigatran for upto 4 days prior to surgery depending on renal function and type of surgery see table above. Low risk patient - No need for therapeutic tinzaparin pre-op. Day of surgery, receive prophylactic dose of tinzaparin 6 hours post-op. Continue routine thromboprophylaxis until dabigatran restarted 3-4days after surgery (or at discretion of surgeon/anaesthetist) High risk patient Patient to receive therapeutic tinzaparin on the pre-operative days when dabigatran omitted. Day of surgery, receive prophylactic dose of tinzaparin 6 hours post-op and restart dabigatran 3-4days after surgery (or at discretion of surgeon/anaesthetist). Start therapeutic tinzaparin on the day after surgery and discontinue when NOAC restarted. VTE Group Dec 2013

37 Appendix 6 Tinzaparin Shared Care Protocol Policy Title: Executive Summary: Shared Care Protocol for Tinzaparin This shared care agreement is to promote the on-going care and support of patients prescribed long term treatment with low weight molecular heparin (LMWH). Supersedes: New policy Description of N/A Amendment(s): This policy will impact on: Patients discharged from hospital on LWMH for certain indications Financial Implications: Limited financial impact. Policy Area: Trust Wide Document Reference: Version Number: 1.1 Effective Date: June 2014 Issued By: Author: (Full Job title ) Chair of Medicines Management Medicines Management Pharmacist Consultant Haematologist APPROVAL RECORD Review Date: May 2017 Impact Assessment Date: Consultation: All Consultants Committees / Group Date Medicines Management Group Area Prescribing Committee Approved by Director: Received for information: Director of Finance and Performance OMT

38 1 Introduction / Purpose This shared care agreement is to promote the on-going care and support of patients prescribed long term treatment with low weight molecular heparin (LWMH). The guidance has been approved by the Medicines Management Group and Area Prescribing Committee after consultation with GP s and CCG. The guidance is felt to represent a safe level of clinical care for patients requiring treatment with LWMH. After initial prescribing under hospital supervision, monitoring and prescribing can be undertaken in general practice under certain circumstances. It is the policy of the Trust that no one will be discriminated against on grounds of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex or sexual orientation. The Trust will provide interpretation services or documentation in other mediums as requested and necessary to ensure natural justice and equality of access. 2 General Document Principles LMWHs are considered to be safer than warfarin and other oral anticoagulants for the treatment and prophylaxis of venous thromboembolism (VTE) in certain groups of patients. Shared care agreements between primary and secondary care are in place for the following patients groups Cancer patients who are not currently undergoing active treatment (for example palliative patients) Patients in which oral anticoagulants are contraindicated or unsuitable (for example patients with liver disease or patients who have had recurrent venous thromboembolisms whist taking oral anticoagulants) Exclusions from the shared care protocol Patients with the following conditions are excluded from this protocol: History of Heparin Induced Thrombocytopenia (HIT) Pregnancy Significant hepatic impairment Thrombocytopenia with platelet count less than 100 Severe hypertension Recent cerebral haemorrhage Recent neurosurgery or eye surgery Active gastric or duodenal ulceration or oesophageal varices Haemophilia and other inherited bleeding disorders Hypersensitivity to heparin, low molecular weight heparins or any other constituent Acute bacterial endocarditis Children under 16 years of age Undergoing active cancer treatment

39 Tinzaparin is the LWMH of choice at ECT The tinzaparin doses for treatment and prophylaxis of VTE for patient groups are follows as Prophylaxis of VTE: 4500 units daily 3500 units daily if egfr less than 20mls/min 2500 units daily in men and women <50kg For patients weighing above 100kg, the following dose adjustments are required: Bodyweight (kg) Prescribed Dose Tinzaparin(IU) Tinzaparin Syringe Size (give once daily) (units) ,000 2 x 2, ,000 2, , ,000 2 x 3, ,000 3, , ,000 2 x 4,500 Note:For patients weighing > 100kg and egfr <20mls/minute, discuss with consultant haematologist.please note that the dose regime above does not apply to pregnant patients Treatment of VTE 175 units per kg of bodyweight daily If egfr less than 30mls/min change to enoxaparin 1mg per kg of bodyweight once daily Patients who are commenced on tin zaparin at East Ches h ir e NHS Trust ( ECT ) must be fully informed of their treatment and, if appropriate, be trained on how to administer the subcutaneous injection. On initiating tinzaparin, the consultant must ensure the following is documented on the discharge (ednf) or clinic letter Clear indications and/or clear rationale for commencing tinzaparin Clear duration or review date Dose and weight. Any calculated dose should be rounded up or down to the nearest measurable dose. Clear monitoring requirements and frequency. As part of this shared care agreement, it is ECT s responsibility to ensure that patients/carers have been trained on how to inject the medication as well as being given required equipment such as sharp bins and swabs. If the patient/carer is unable to administer the injection, ECT must refer the patient to the community district nursing team.

40 ECT clinicians must ensure the patient/carer has been provided with information regarding the dose and frequency of the injections as well as any side-effects and warning signs and who to contact if any side-effects or warning signs occur. ECT is responsible for supplying upto a month and no less than 2 weeks tinzaparin and arranging monitoring within the first 14 days of treatment if required (see below). ECT monitoring requirements - platelets Heparin induced thrombocytopenia (HIT) is a rare side effect of heparin including LMWH. Thrombocytopenia, should it occur, usually appears between days 5 and 14 of treatment. The British Committee for Standards in Haematology guideline states routine monitoring of platelets is not required. 1 All patients must have a platelet count before starting treatment. Post-cardiopulmonary bypass patients receiving LMWH should have platelet count monitoring performed every 2 3 days from days 4 to 14 or until heparin is stopped 1 Post-operative patients and cardiopulmonary bypass patients who have been exposed to heparin in the previous 100 days and are receiving any type of heparin should have a platelet count determined 24 hours after starting heparin 1 ECT monitoring requirements general (all patients) Patients must have a recent egfr to ensure they are prescribed the correct dose. Heparin can suppress adrenal secretion of aldosterone leading to hyperkalaemia. Potassium should be monitored before and during treatment in patients at risk e.g. renal impairment, diabetes mellitus and patients taking potassium sparing drugs. The referring consultant will specify if and with what frequency potassium should be monitored. Routine anti-xa activity monitoring is not usually required but may be considered in patients at risk of under or over anticoagulation, e.g., in those with renal or hepatic impairment. The referring consultant will specify if and with what frequency anti-xa should be monitored. For drugs affecting haemostasis, e.g., antiplatelets, NSAIDs, systemic glucocorticoids, thrombolytics and anticoagulants - if the combination cannot be avoided tinzaparin should be used with careful clinical and laboratory monitoring. Primary care monitoring requirements Regular potassium monitoring in high risk patients i.e. diabetes mellitus, chronic renal failure, acidosis, raised potassium levels, patients taking potassium-sparing drugs or potassium supplements or patients on long-term treatment (minimum annually or more frequently as appropriate). Patients weight adjust dose of tinzaparin if required, accordingly if weight alters. Monitor renal function dose may need adjusting if renal function deteriorates - (please refer to product literature

41 Side effects Most common side effects from LMWH are related to bleeding and the increased tendency to bleed. Localised pain, bruising and irritation at the injection site are common. LMWH may cause hypoaldosteronism resulting in hyperkalaemia, but this is unlikely in the absence of an additional cause of hyperkalaemia. Heparin-Induced thrombocytopenia (HIT) can occur with LMWH. It usually presents between 5 and 14 days after starting therapy. This should be considered if platelet count falls below the normal range, or to less than 30-50% of baseline platelet count. Other rare adverse effects include systemic allergic reactions including anaphylactoid reactions, skin necrosis at the injection site, increase in liver enzymes, and osteoporosis with prolonged therapy. This guidance does not replace the SPC, which should be read in conjunction with this guidance accessible at Unlicensed prescribing of tinzaparin Tinzaparin is unlicensed in the following indications Prophylaxis of deep-vein thrombosis in medical patients Secondary prophylaxis of deep vein thrombosis and pulmonary embolism in patients with cancer, intravenous drug abusers and intolerance/poor control of oral anticoagulation. ECT Medicines Management Group approves the prescribing of tinzaparin in the above unlicensed indications in accordance with established clinical practice. 3 Definitions LWMH Low weight molecular heparin Tinzaparin a low molecular weight heparin DVT deep vein thrombosis PE pulmonary embolism MMG Medicines Management Group 4 Associated Documents ECT Guidelines for the Prevention and Treatment of VTE in Medical and Surgical Patients Medicines Policy 5 Duties MMG

42 To develop, disseminate and review this shared care documentation. Clinicians at ECT Ensure the patient has been given all the required information and that they have been informed of side-effects and monitoring requirements. Ensure the patient has undergone the required blood tests. Ensure that all relevant investigations have been performed prior to transfer of the patient back to primary care. Ensure a comprehensive care summary is provided to primary care including the indication/rationale for treatment, dose, duration and monitoring arrangements Advise on dosage alterations where appropriate. Respond to primary care queries in a timely manner Pharmacy at ECT Ensure the discharge letter (ednf) has been completed correctly and appropriately. Ensure the patient has a supply of tinzaparin as indicated in the discharge letter or as per this shared care agreement General practitioners Provide the patient with prescriptions for tinzaparin as required Ensure systems are in place for daily administration of tinzaparin if the patient is not self-administering. Monitor the patient s bloods, renal function and potassium as requested by the shared care agreement or as per consultant advice. Check dose is appropriate for patient s weight and renal function Ensure the medication is added to the GP patient record Monitor the patients overall health and wellbeing Monitor the patient for adverse drug reaction and remain vigilant to risk of potential drug interaction Associated Documents British National Formulary Summary of Product Characteristics - Tinzaparin. 6 Consultation and Communication with Stakeholders MMG Area Prescribing Committee General Practitioners 7 Implementation This shared care agreement will be implemented via the Trust Intranet and the CCG MMG members. 8 Education and Training This shared care agreement will be made available to secondary care and primary care prescribers when patients are commenced on long term tinzaparin

43 Appendix 7 Root Cause Analysis Form for Hospital Associated Thrombosis HOSPITAL ASSOCIATED THROMBOSIS Venous Thromboembolism occurring during hospital admission or within 90 days of discharge from hospital Date of RCA review Date of review by VTE group Date RCA approved by the VTE group Comments/Recommendations by the group Date of shared learning with the Clinical Audit meeting and Speciality SQS Root Cause Analysis Section One Patient Details and VTE Diagnosis Patient Name Hospital Number DOB Has the patient been discharged from hospital within the last 90 days VTE diagnosis (DVT/PE/both) Symptomatic/Asymptomatic Date of VTE diagnosis Patient location at time of diagnosis Date USS / V/Q scan performed Date thromboprophylaxis started Section Two Index Hospital Admission Details Ward Consultant Admission Date Discharge Date If patient deceased, cause of death (state if cause of death may be due to VTE) Date of surgery Reason for admission Section Three Thromboprophylaxis Hospital Admission VTE Risk Assessment O/A Date completed VTE Risk High / Low VTE Risk Assessment at 24 hours Date completed VTE Risk High/Low

44 Weekly VTE Risk Assessments Date(s) completed VTE Risk High/Low Thrombotic Risk Factors (tick/circle all present) Active cancer/treatment Age 60> THR TKR HFS Known thrombophilia Dehydration Obesity (BMI>30) Medical Comorbidity Surgery plus anaesthetic time >90 mins Pelvic surgery plus anaesthetic time >60 mins Acute surgical admission with inflammatory or intra-abdo condition Critical care admission Details:- Personal?FHx VTE Surgery with significant reduction in mobility COCP HRT Varicose veins with phlebitis Pregnancy/<6w post partum Contraindications to TP (tick/circle all present) Active bleeding Acquired bleeding disorder Concurrent anticoagulants Acute stroke Thromboctytopenia Neurosurgery, spinal surgery or eye surgery Other procedure with high bleeding risk LP/epidural/spinal expected in the next 12 h LP/epidural/spinal in past 4 h Uncontrolled systolic hypertension Untreated inherited bleeding disorder Mechanical TP used? Date mechanical TP commenced Date mechanical TP ceased Chemical TP prescribed? Type of chemical TP

45 Dose of chemical TP Date commenced Date ceased Chemical TP administered as prescribed? i.e. any missed doses Patient weight Patient creatinine clearance Extended TP prescribed? VTE risk assessed appropriately Patient information/discharge advice documented Section Four Root Cause Analysis by Consultant/Lead Clinician Comments for consideration: In retrospect, could increased risk of VTE have been predicted during index hospital admission? Was increased risk of VTE recognised during index admission? Was VTE risk assessment undertaken? Was thromboprophylaxis prescribed in accordance with East Cheshire NHS Trust guidelines? Was thromboprophylaxis given in accordance with East Cheshire NHS Trust guidelines? Could this episode of VTE have been prevented? How? What changed could be implemented to prevent VTE in this situation in the future? Has this case changed your practice? Do you have any plans to implement changed in your/your team s practice pertaining to VTE prevention? If so, please state changes and timescale Completed by Name Signature Date

46 Appendix 8 Pathway for District Nurse Administration of Tinzaparin Tinzaparin pathway Patient prescribed tinzaparin Encourage patient/family or carer administration Assess ability/capacity yes Teach injection technique 48 hours before discharge Negotiate time of injection Provide leaflet, drug and sharps bin Ensure contact details provide for support N O Patient/family or carer unable to administer drug Refer to District Nurse yes Is the patient housebound no Refer to Practice Nurse Essential on discharge Referral with reason for treatment and duration Signed community prescription sheet with drug name, dose and patient weight. Correct quantity of injections Sharps box Patient information leaflet with contact details for support Time that injection should be given Date of approval March 2014 Review date March 2015 Ratified by Acute Business Unit-VTE Group Author Michelle Kurzawa

47 Appendix 9 VENOUS THROMBOEMBOLISM (VTE) PROTOCOL FOR EXCEPTION AND COHORT GROUPS AT ECNHST October 2015 Introduction In line with Department of Health VTE guidelines and NICE guidance (CG92) and with local agreement, there are a group of patients that are either detailed in the co-hort below or are included in the exclusion category that do not require a risk assessment as they have been agreed to be either low risk or are detailed as a category of patient that do not require risk assessment. The Cohort includes the following categories of patient:- All haematology, chemotherapy and rheumatology day cases Anyone admitted to medical day case unit and discharged the same day after their treatment Day case eye surgery under local anaesthetic All endoscopy day case patients All radiological interventions undertaken as a day case All dental surgery under local anaesthetic Gynae suite procedures completed under local anaesthetic (New Alderley House patients) Non-cancer ENT surgery lasting less than 90 minutes with local anaesthetic/ regional/ sedation and not full general anaesthetic Non-cancer plastic surgery lasting less than 90 minutes with local anaesthetic/regional/ sedation and not full general anaesthetic Orthopaedic surgical procedures performed as a day case and with local anaesthetic /regional/ sedation and not full general anaesthetic Exclusion from VTE Risk Assessment are in the following categories:- Patients under the age of 18 (i.e. 17 years or less) Patients attending hospital as outpatients Patients attending emergency department/assessment areas for example the Ambulatory Assessment Unit (AAU) and Surgical Assessment Unit (SAU) who are not admitted to hospital including ward attenders. Any patient who is subsequently admitted or bedded down in these areas as an in-patient will require VTE risk assessment exception being only those patients who are admitted to the ward for a short period whilst waiting for discharge. Any patient who is cancelled after admission for surgery who is subsequently discharged on the same day Patients who are admitted to hospital because they have a diagnosis or signs and symptoms of DVT or pulmonary embolism. The Trust confirms that these groups have been assessed as suitable for inclusion in the list of cohorts at ECNHST using the DoH VTE risk assessment proforma and Nice Guidance and would not require an individual risk assessment proforma completing. Following assessment the Medical Director and the Clinical Directors of each Service Line will authorise inclusion of the patient groups and final sign-off will be made by the Executive Medical Director of the Trust. ECNHST Medical Director Name Signature

48 Appendix 10 Treatment of Pulmonary Embolism and Massive Pulmonary Embolism pathway Pulmonary Embolism RECOGNITION Pulmonary venous thromboembolism (PE) is often missed clinically Suspect the diagnosis in any patient who does not respond to initial therapy, or in whose condition there has been an unexplained deterioration Most episodes follow popliteal or iliofemoral DVT PE is easily missed in: severe cardiorespiratory disease elderly patients PE is rare if age <40 yr with no risk factors Symptoms and signs (signs may be absent) Small emboli present with dyspnoea, whereas moderate-sized emboli present with signs of infarction and pleuritic pain Dyspnoea (present in 90% of cases) may be of sudden onset Pleuritic chest pain Haemoptysis Syncope Tachypnoea (>20 breaths/min) Fever Pleural rub Tachycardia Differential diagnosis Pneumonia Myocardial infarction (MI) Exacerbations of asthma and COPD ASSESSMENT Confirming diagnosis ECG and chest X-ray are often normal and should not be used to confirm/refute the diagnosis, but are useful for identifying other diseases and explaining symptoms. ECG may show sinus tachycardia, an S1 Q3 T3 pattern, right bundle branch block, P pulmonale or right axis deviation. Chest X-ray may show non-specific shadows or a raised hemidiaphragm, pulmonary oligaemia, linear atelectasis or small pleural effusion Determine two-level PE Wells score (Table 1)

49 Table 1: Two-level PE Wells score Clinical feature Points Symptoms and signs of DVT (minimum leg swelling and pain with palpation of deep 3 veins) An alternative diagnosis is less likely than PE 3 Heart rate >100 beats/min 1.5 Immobile for >3 days or surgery in previous 4 weeks 1.5 Previous DVT or PE 1.5 Haemoptysis 1 Malignancy (currently being treated, treated in last 6 months, or palliative) 1 Clinical probability simplified score PE likely PE unlikely >4 points <4 points MANAGEMENT OF A NON-PREGNANT PATIENT Investigations follow Flowchart If indicated by two-level PE Wells score, request D-dimer assay many clinical states apart from PE (see Table 2) can raise D-dimer concentration do not request if clinical probability of PE is high, in probable massive PE or where an alternative diagnosis is highly likely,. Only a negative result is of value In patients with clinical DVT, leg Doppler ultrasound is alternative to lung imaging FBC, INR, APTT Table 2: Common causes of raised D-dimer concentration Acute myocardial infarction (MI) Pregnancy Chronic subdural haematoma Recent surgery Disseminated intravascular coagulation Renal disease Gram-negative bacteraemia Rheumatoid disease Leukaemia Sickle cell crisis Liver disease Subarachnoid haemorrhage Metastatic malignancy Thrombolytic therapy Peripheral vascular disease Trauma with pathological thrombosis Whereas a normal D-dimer concentration virtually rules out thrombosis, a raised D-dimer concentration cannot be used confidently to confirm that thrombosis has occurred Management of a Pregnant Patient See Trust guidelines for Venous Thromboembolism in pregnancy and the puerperium available on the trust intranet under Clinical Guidelines

50 Flowchart for diagnosis of PE Two-level Wells score PE likely (>4 points) PE unlikely (<4 points) Start LMWH*, ** D-dimer assay egfr>50ml/min Positive Negative Start LMWH* Yes No Discuss with Reg/Cons (may need alternative imaging such as leg Dopplers or V/Q scan Positive CTPA Negative *Assess suitability for outpatient management. See outpatient management of PE pathway. ** choice of LMWH dictated by egfr (see later) Is DVT suspected? Yes No Doppler of leg. See DVT guideline Alternative diagnosis Consider warfarin (unless active malignancy) for at least 6 months

51 IMMEDIATE TREATMENT (If haemodynamically unstable, please see management of massive PE pathway) General Oxygen see Oxygen therapy in acutely hypoxaemic patients guideline Adequate analgesia for pleuritic pain paracetamol alone is unlikely to be adequate. If swallowing difficulties or NBM and using IV paracetamol, patients under 50kg should be dosed at 15mg/kg/dose, if well hydrated and egfr >50 ml/min, ibuprofen 400 mg oral 8-hrly in dehydrated patient or if egfr 20-50ml/min, use Ibuprofen at normal dose, but avoid if possible (as per Renal Drug Handbook 3 rd edition) to prevent renal damage. Alternatively, use morphine sulphate 10 mg oral 4-hrly. Be aware than Morphine can accumulate in renal failure, therefore monitor for side-effects and use the following guidelines: If egfr 20-50ml/min use 75% of normal dose, If egfr 10-20ml/min use smaller doses i.e 2.5-5mg and extend dosage interval. Titrate according to response. If egfr <10ml/min use smaller doses i.e. 1.25mg-2.5mg and extend dose interval. Titrate according to response. Ref: Renal Drug Handbook 3 rd Edition ibuprofen may be substituted once adequate fluid replacement achieved if egfr 50 ml/min avoid NSAIDS, including ibuprofen, if patient taking ACE inhibitor A high right atrial pressure (i.e. JVP) is common and does not need to be treated AVOID diuretics If patient pregnant, see trust guidelines for venous thromboembolism in pregnancy and the puerperium available on the trust intranet. Specific Commence Tinzaparin treatment dose of 175units/kg as soon as PE suspected if egfr >30ml/min. If egfr <30ml/min start Enoxaparin at a dose of 1mg/kg See Trust VTE guideline If anticoagulation contraindicated, a consultant physician, staff physician or SpR must decide which carries most risk possible complications of therapy or embolism and consider a vena caval filter SUBSEQUENT MANAGEMENT Daily clinical examination for signs of further embolism, right heart failure, and secondary infection of a pulmonary infarct Monitoring Tinzaparin treatment See Trust VTE guideline Maintenance anticoagulation Start warfarin as soon as diagnosis confirmed see Warfarin guidelines Continue low molecular weight heparin for at least 5 days or when INR has, for two consecutive days, been within the therapeutic range: 2 3 (3 4 for recurrent PE occurring while INR within range 2 3), whichever is the longer If there are compliance issues, consider continuing therapeutic Tinzaparin treatment, rather than converting to warfarin Rivoroxaban is an option for treating PE and preventing recurrent DVT and PE in adults as per NICE CG 287. However, do not initiate without prior discussion with the respiratory consultant or consultant haematologist.

52 Patients with active cancer or receiving cancer treatment Therapeutic tinzaparin treatment is the preferred treatment option over oral anticoagulants due to the difficulty in maintaining INR control in these patients. INR may be elevated by heparin if APTT ratio exceeds 2.5 in a patient being given unfractionated heparin, and must not be used as a guide to adjustment of warfarin dosage Screen for cancer Chest X-ray, FBC, LFT, calcium and urinalysis in all patients with a confirmed PE If patient aged <60 yrs has first unprovoked PE, consider performing an abdominal pelvic CT scan and (for women) a mammogram DISCHARGE AND FOLLOW-UP Clinical Ensure INR in appropriate range and stable After a first thromboembolic event, continue warfarin for 6 months. Continue indefinitely for recurrent or life-threatening PE and unprovoked PE If patient has active cancer, reassess risks and benefits of continuing anticoagulation at 6 months Administrative Advise patient that many drugs (including alcohol) interact with warfarin and to remind their GP, if additional medication is prescribed, that they are taking warfarin Give patient a yellow anticoagulation therapy record booklet in which the following information has been entered: indication for warfarin, target INR, start date and duration of therapy, the last 4 INR results and date of next INR Refer to anticoagulant management service for follow-up appointment date obtain anticoagulant referral form from hospital intranet: Clinicians>support services>pathology>anticoagulant management If hospital supervision planned, ensure discharge letter includes diagnosis, dosage of warfarin and date of clinic appointment If anticoagulation is to be monitored by GP, supply GP with written information in discharge letter about: indication for anticoagulation proposed duration of treatment proposed target range for INR details of anticoagulation in hospital (give dates, INR results and dosage taken) Document in notes that patient has been given written and verbal information about warfarin and has been referred to anticoagulation clinic

53 MASSIVE PULMONARY EMBOLISM SYMPTOMS AND SIGNS Massive PE highly likely if there is: Collapse/hypotension Unexplained hypoxia Engorged neck veins Right ventricular gallop (often) Cardiac arrest. Blue light patients with out-of-hospital cardiac arrest due to PE rarely recover MANAGEMENT General See pulmonary embolism guideline PREGNANCY If pregnant, see trust guidelines for venous thromboembolism in pregnancy and the puerperium available on the trust intranet under Clinical guidelines Assess clinical state Cardiac arrest Deteriorating Condition seems stable (1) Resuscitation (CPR) (2) Alteplase 50 mg IV (3) Reassess after 30 min (1) Contact consultant (2) Alteplase 50 mg IV (3) Urgent echocardiogram/ctpa (1) Unfractionated heparin immediately see IV unfractionated heparin guideline (2) Urgent echocardiogram/ctpa In event of deterioration D-dimer is not relevant in probable massive PE Thrombolysis If life-threatening features (right heart failure, shock) present, give alteplase 50 mg IV as bolus injection Failure to respond to alteplase is an indication for emergency direct thrombolysis, catheter thrombo-embolectomy or pulmonary embolectomy. Contact interventional department/interventional radiologist and cardiothoracic surgeon to discuss. If it is felt that right heart catheter monitoring would be helpful, arrange to transfer patient to Critical Care If patient haemodynamically unstable, consider thrombolysis If patient stable (with no systemic hypotension), only consider thrombolysis if they have: echocardiographic evidence of right ventricular dysfunction or free-floating right ventricular thrombus. Discuss this with on call consultant. If thrombolysing, give alteplase 10 mg by IV injection over 1 2 min, followed by 90 mg by IV infusion over 2 hr (max 1.5 mg/kg in patients weighing <65 kg) If not thrombolysing, anticoagulate:

54 If there are contraindications to giving alteplase or anticoagulation, a consultant physician, or SpR must make a decision as to which carries most risk possible complications of therapy, or embolism Post-thrombolysis After thrombolytic therapy has ceased, wait until APTT ratio has fallen below 2 before commencing or recommencing anticoagulation as follows: in all patients, start with unfractionated heparin with no loading bolus see IV unfractionated heparin guideline. In pregnant women, monitor anti-xa concentration as a guide to dosage adjustment if not pregnant, consider Warfarin although LMW Heparin may be more appropriate in some circumstances. Discuss with consultant and follow Management of PE pathway.

55 EAST CHESHIRE NHS TRUST OUTPATIENT DEEP VEIN THROMBOSIS PROFORMA Affix patient ID label DATE OF ATTENDENCE: / / NURSING STAFF TO FILL IN PAGE 2 INITIAL ASSESSING CLINICIAN TO FILL IN PAGES 3, 4, 5 & 7 ALL OTHER PAGES FOR DVT CLINIC TO FILL IN Inclusion Criteria Patients presenting with clinical suspicion of deep vein thrombosis (DVT) and who are eligible for outpatient management Exclusion Criteria INPATIENT CLERK ON GREEN MEDICAL PROFORMA Patient is currently warfarinised and in therapeutic INR range Known bleeding disorder or platelets < 75 (10^9/L) Abdominal aortic aneurysm Major surgery within previous 1 month Gastro-intestinal bleed past 1 month Intracerebral bleed past 6 months Hypertension > 180/100 (if >80 years BP >200/100) Co-morbidities requiring admission Patient with no social support Patient with memory impairment Pregnant patients

56 Name: DOB: Hospital No: NHS No: INITIAL NURSING ASSESSMENT Name of Assessing Nurse (print): Signature: A: Maintain own airway Yes No B: RR: /min SaO 2 %: FiO 2 : (l/min or %) C: BP: Pulse: /min CR Time: / secs D: A V P U (circle) BM: /mmols E: Temp: Pain Score 0 10: Rt Calf circumference (cm): Lt Calf circumference (cm): WEIGHT (Kg) Urine Dipstick: * REQUEST BLOODS FOR FBC UEs LFTs INR/APPT D-dimer * Date PRESENTING PROBLEM AND PREVIOUS MEDICAL/NURSING HISTORY Signed

57 Name: DOB: Hospital No: NHS No: CLINICAL HISTORY AND EXAMINATION NOTES Source of Referral: Date/Time of Assessment: Location (Please circle): A&E / AAU / MAU Name & Grade of Assessing Practitioner (Please print): HISTORY OF PRESENTING COMPLAINT GP letter received: Yes No N/A PAST MEDICAL HISTORY PREVIOUS DVT Yes No PREVIOUS PE Yes No CURRENT MEDICATIONS ALLERGIES: Obtained from: Patient: GP Letter: Relative/Carer: Other: SOCIAL HISTORY Occupation: Smoking details:

58 Alcohol Intake: IVDU History: Name: DOB: NHS No: PHYSICAL EXAMINATION General Remarks CARDIOVASCULAR EXAMINATION (RECORD RELEVANT DETAILS) RESPIRATORY EXAMINATION (RECORD RELEVANT DETAILS) ABDOMINAL EXAMINATION (RECORD RELEVANT DETAILS) UPPER / LOWER LIMB EXAMINATION

59 Name: DOB: Hospital No: NHS No: WELLS SCORE Use Wells Score and D-Dimer for Algorithm 1 Next Page RESULTS OF INITIAL INVESTIGATIONS Hb: MCV: Sodium: LFTs: WBC: Potassium: Platelets: Urea: