VENOUS THROMBOEMBOLISM PROPHYLAXIS POLICY

Transcription

1 VENOUS THROMBOEMBOLISM PROPHYLAXIS POLICY Document Author Written By: Senior Pharmacist Medicines Information Date: January 2016 Authorised Authorised By: Chief Executive Date: 8 March 2016 Lead Director: Executive Medical Director Effective Date: 8 March 2016 Review Date: 7 March 2019 Approval at: Policy Management Group Date Approved: 8 March 2016 Version No. 4.0 Page 1 of 22

2 DOCUMENT HISTORY Date of Issue Version No. Date Approved Director Responsible for Change 3 Sep Sep 12 Dr M Pugh Karen Baker 21 Nov Executive Medical Director Nature of Change Ratification / Approval Reviewed in line with NHSLA standards Approved Executive Board 6 Dec Agreed at Quality & Patient Safety Group with amendments 14 Dec Agreed at Policy Management Group 17 Dec Dec 12 Executive Medical Director Executive Medical 08 Mar Director 29 Jan Executive Medical Director 08 Mar Mar 16 Executive Medical Director 23 Mar 16 4 Executive Medical Director Medical Director/Pharmacist & Governance / Risk Review, reformat and updates For ratification For Approval For consideration NB This policy relates to the Isle of Wight NHS Trust hereafter referred to as the Trust Approved at Executive Board Clinical Standards Group Policy Management Group SEE Version No. 4.0 Page 2 of 22

3 Contents Page 1. Executive Summary Introduction Definitions Scope Purpose Roles and Responsibilities Policy detail/ Course of action Consultation Training Monitoring Compliance and Effectiveness Links to other Organisational Documents References Appendices. 10 Version No. 4.0 Page 3 of 22

4 1. Executive Summary This policy is intended to assist with the reduction of Veus Thromboembolism (VTE) associated with possible fatal and n-fatal pulmonary emboli, chronic veus insufficiency, veus ulceration and the development of post-thrombotic syndrome, through the effective use of thromboprophylaxis. Nationally it is believed 25,000 patients per year die from hospital acquired VTE, many are preventable. This policy aims to reduce VTE by ensuring that guidance is available to staff and all adult (over 18 years old) admissions receive a risk assessment and, where appropriate, are prescribed adequate thromboprophylaxis to prevent veus thromboembolism. This policy does t cover Maternity or Paediatric Services 2. Introduction VTE is the formation of a blood clot (thrombus) in a vein which may dislodge and cause an embolism. Blood flow through the affected vein can be limited by the clot, causing swelling and pain. Most thrombi form in the deep veins of the legs and pelvis and are termed deep vein thrombosis (DVT). Dislodged thrombi may travel to the lungs, causing a Pulmonary Embolus (PE) which can be fatal. Thrombi can also cause long term morbidity such as post thrombotic syndrome. Veus thrombosis can form in any part of the veus system. However, DVT and PE are the most common manifestations of veus thrombosis, collectively kwn as veus thromboembolism. VTE is a significant cause of death in hospital patients and treatment of n-fatal symptomatic VTE and related long-term morbidities is associated with considerable cost to the health service. The House of Commons Health Committee reported in 2005 that an estimated 25,000 people die each year from preventable hospital-acquired VTE. Risks of thrombus formation increase with length of surgical procedures and increased periods of immobility. The inconsistent use of prophylactic measures for VTE in hospital patients has been widely reported, as has the poor completion rates of VTE risk assessments documented within the patient s tes. The National Institute for Health and Care Excellence (NICE) Clinical Guideline 92; Veus Thromboembolism; Reducing the Risk (6) offers best practice advice on reducing the risk of VTE in patients admitted to hospital. NICE defines the Trust quality standards required. Statement 1. All patients, on admission, receive an assessment of VTE and bleeding risk using the clinical risk assessment criteria described in the national tool Statement 2. Patients/carers are offered verbal and written information on VTE prevention as part of the admission process Statement 3. Patients fitted with anti-embolism stockings have them fitted and monitored in accordance with NICE guidance. Statement 4. Patients are re-assessed within 24 hours of admission for risk of VTE and bleeding. Statement 5. Patients assessed to be at risk of VTE are offered VTE prophylaxis in accordance with NICE guidance Statement 6. Patients/carers are offered verbal and written information on VTE prevention as part of the discharge process. Statement 7. Patients are offered extended (post hospital) VTE prophylaxis in accordance with NICE guidelines. Version No. 4.0 Page 4 of 22

5 3. Definitions NICE have defined veus thromboembolism as: VTE is a condition in which a blood clot (thrombus) forms in a vein. It most commonly occurs in the deep veins of the legs; this is called deep vein thrombosis. The thrombus may dislodge from its site of origin to travel in the blood a phemen called embolism." Pulmonary embolism is when a thrombus travels to the lung. Major bleeding: a bleeding event that results in one or more of the following: o death o a decrease in haemoglobin concentration of 2 g/dl o transfusion of 2 units of blood o a surgical or medical intervention o bleeding into a retroperitoneal, intracranial or intraocular site o a serious or life-threatening clinical event Significantly reduced mobility: o bed bound, unable to walk unaided or likely to spend a substantial proportion of the day in bed or in a chair Abbreviations AES: Antiembolism stockings [formerly kwn as TED] APTT: Activated partial thromboplastin time BMI: Body Mass Index DOAC: Direct acting oral anticoagulant (also kwn as NOAC) DVT: Deep vein thrombosis EPMA: Electronic Prescribing & Medicines Administration system (JAC) HIT: Heparin-induced thrombocytopaenia INR: international Normalised Ratio LMWH: Low molecular weight heparin NOAC: New (vel) oral anticoagulant PAAU: Pre-assessment and Admissions Unit PE: Pulmonary embolism SC: Subcutaneous SIRI: Serious incident requiring investigation THR: Total hip replacement TKR: Total knee replacement UFH: Unfractionated heparin VTE: Veus thromboembolism 4. Scope This document applies to all health professionals involved in the delivery of care or treatment of adult (over 18 years old) in-patients and day case admissions to the Isle of Wight NHS Trust. Excludes maternity and paediatric services. Version No. 4.0 Page 5 of 22

6 5. Purpose The purpose of this document is to appropriately reduce the risk of a patient developing VTE whilst under the care of the Isle of Wight NHS Trust I. This policy aims to ensure every patient is assessed according to national best practice guidance for their risk of veus thromboembolism and their bleeding risk. II. III. It provides appropriate risk assessment tools. The policy sets out on the mechanical and pharmacological options to be provided for VTE prophylaxis. 6. Roles and Responsibilities Thromboprophylaxis remains the responsibility of the Consultant and his/her multidisciplinary team. All clinicians admitting routine or emergency cases have a responsibility to ensure a clinical VTE risk assessment is conducted and documented, taking account of the patients overall risk of thrombosis versus risk of bleed, and prescribing the appropriate thromboprophylaxis. Nurses have a responsibility to ensure that prescribed thromboprophylaxis is administered in a timely manner. Pharmacy staff have a responsibility to ensure that pharmacological thromboprophylaxis has been prescribed appropriately following assessment, is readily available, and that a pharmacist is available to provide advice when needed. Nurse managers have a responsibility for ensuring nurses receive training in correct use of antiembolism stockings and intermittent pneumatic compression devices. All of these staff groups are responsible for ensuring that the patient has received the relevant information regarding VTE and thromboprophylaxis. All of these staff groups have a responsibility to maintain their kwledge and competency regarding the risks of thromboembolism and need for VTE prophylaxis and the prophylactic options available. The Haematologist will have responsibility for providing advice in situations lying outside the scope of these guidelines e.g. HIT, allergy or thrombocytopaenia. 7. Policy detail/ Course of Action 7.1 Reducing the Risk of VTE for All Patients Assess and document level of mobility, VTE and bleeding risk for all patients admitted to IWNHS Trust. Ensure patients are provided with information on VTE risk and prevention on admission. Encourage all patients to mobilize early (as appropriate). Avoid patients becoming dehydrated. Consider referral for temporary inferior vena cava filters for those patients who are at very high risk of VTE (such as patients with a previous VTE event(s) or active malignancy) if mechanical and pharmacological VTE prophylaxis are contraindicated. Version No. 4.0 Page 6 of 22

7 Do t regard aspirin or other antiplatelet agents as adequate prophylaxis for VTE All patients defined as admitted to hospital must be assessed using a Trust approved VTE risk assessment tool, in line with National Guidance (6,7) Medical patients who are NOT expected to have significantly reduced mobility relative to rmal state are t regarded at increased VTE risk. However the clinical condition of each inpatient will need to be reviewed and their VTE risk reassessed if there is any deterioration in their condition and mobility status All patients should be assessed for risk of bleeding prior to offering pharmacological VTE prophylaxis. Pharmacological VTE prophylaxis should t be prescribed in patients with any risk factors for bleeding, unless the risk of VTE outweighs the risk of bleeding The VTE Risk assessment should be completed on the JAC Electronic Prescribing and Administration system at the point of admission or at pre-assessment. If EPMA is t available the risk assessment should be documented in the patient s tes Each Patient s risk of VTE must be assessed on admission reviewed and reassessed within 24 hours of admission, especially if there is any change in the clinical picture VTE risk should be regularly reviewed thereafter, and appropriate prophylaxis must be given Regular review is required to assess appropriateness and be able to identify any adverse effects resulting from VTE prophylaxis at an early stage For routine surgical patients the initial VTE risk assessment should take place in the Pre- Admission Assessment Unit (PAAU) and should be confirmed by a clinician on admission The clerking clinician should conduct a VTE risk assessment for each medical and emergency surgical admission, prescribing VTE prophylaxis when appropriate Separate Maternity VTE guidelines should be followed. All pregnant women should undergo an assessment of risk factors for VTE during their booking appointment. This assessment should be repeated if the woman develops other intercurrent problems and with every admission to hospital. Those women identified at risk should be referred to the first available consultant antenatal clinic for consideration of antenatal thromboprophylaxis. A further assessment should be made by the midwife immediately after a rmal delivery and by the obstetrician immediately after an operative delivery Relevant risk factors are contained in the risk assessment documents (Appendix 1 and 2). The identification of a mobility risk factor and at least one thrombosis risk factor during the assessment is an indication that the patient is considered at increased risk of developing VTE during their hospitalisation VTE Prophylaxis for palliative care patients should take into account the views of the patient and their families and carers and the multidisciplinary team. Thromboprophylaxis should be used if the patient has potentially reversible acute pathology e.g. sepsis or a potentially temporary reduction in mobility, and reviewed daily. Version No. 4.0 Page 7 of 22

8 It is t necessary to provide pharmacological or mechanical VTE prophylaxis to patients admitted for terminal care or those commenced on an end of life care pathway. Do t use thromboprophylaxis where risk factors are part of an irreversible progression in the illness (e.g. becoming bedbound due to advancing illness) VTE and bleeding risk should be assessed on admission to the Intensive Care Unit (ICU) and VTE prophylaxis offered according to reason for admission, taking into account planned interventions and other therapies that may increase risk of complications. The risks of VTE and bleeding for patients in ICU should be reassessed daily. Decisions about VTE prophylaxis should be reviewed more frequently if the clinical condition is changing rapidly, taking into account the kwn views of the patient, family and/or carers and the multidisciplinary team. 7.2 Choice of VTE Prophylaxis Options following VTE risk assessment include No intervention Mechanical intervention only. Appendix 4. Pharmacological intervention only. Appendix 5. Both pharmacological and mechanical intervention. Prophylactic measures to reduce the risk of VTE include the use of graduated compression antiembolism stockings, intermittent pneumatic compression or foot impulse devices, low molecular weight heparin, unfractionated heparin or a direct acting oral anticoagulant where appropriate The decision as to which of the above options are chosen is tailored specifically for the patient and their individual clinical circumstances, considering the potential risk of any intervention versus the respective benefit The prophylactic treatment regimen for patients at risk should be in accordance with current NICE Quality Standard (QS3) and related guidance and techlogy appraisals See IW formulary and Appendices for current pharmacological product choice, duration and doses. 7.3 Reporting of confirmed VTE A hospital acquired thrombosis (DVT or PE) is defined as occurring within 3 months of a hospital admission From 1 April 2010, the NHS Standard Contract for acute services requires providers to report to their lead commissioner on root cause analysis of all confirmed cases of hospital acquired PE and DVT (including those arising from a current stay or new events arising where there is a history of admission to hospital within the last three months, but t including patients admitted to hospital with a confirmed VTE with history of an admission to hospital within the last three months) (3)(11) All DVT or PE confirmed either radiologically or by the mortuary must be reported. Version No. 4.0 Page 8 of 22

9 7.3.4 An incident form for patients with hospital acquired thrombosis should be completed, under the direction of the Consultant, preferably by the houseman, and a root cause analysis investigation undertaken. This will be reported as a SIRI if this policy has t been followed for prophylaxis. 8. Consultation Consultation with Trust senior surgical and medical clinicians and members of the Drugs Advisory Committee and Clinical standards Group 9. Training This veus thromboembolism prophylaxis policy has a mandatory training requirement, which is detailed in the Trust s Mandatory Training Needs Analysis and is reviewed on an annual basis. 10. Monitoring Compliance and Effectiveness 1. Compliance with VTE screening is monitored monthly via the Trust Performance report 2. Spot audits will be undertaken yearly to ensure compliance with prescribing guidelines and reported to the Patient Safety, Experience and Clinical Effectiveness Committee 11. Links to other Organisational Documents Guideline for the Prevention and Treatment of Veus Thromboembolism (VTE) in Pregnancy 2012, Mr N Kenney Isle of Wight NHS Trust. Isle of Wight NHS Trust Patient Information Leaflet: Prevention of Blood Clots- Veus Thromboembolism (VTE)- in hospital patients 12. References 1. The Prevention of Veus Thromboembolism in Hospitalised Patients. House of Commons Health Committee; 2005 February. (HC99) 2. Thrombosis: Awareness, Assessment, Management and Prevention. An Audit of Acute Hospital Trusts. All-Party Parliamentary Thrombosis Group. November Prevention of veus Thromboembolism in hospitalised patients. DH Gateway reference number onsandstatistics/lettersandcirculars/dearcolleagueletters/dh_ Prevention of veus Thromboembolism (VTE) in Hospitalised Patients. Gateway Reference Number DoH, May pdf 5. Department of Health (2010) Veus Thromboembolism (VTE) Risk Assessment Version No. 4.0 Page 9 of 22

10 nsandstatistics/publications/publicationspolicyandguidance/dh_ NICE CG92; Veus thromboembolism: reducing the risk for patients in hospital; January Full guideline Quality Standard 7. NICE Pathway: Reducing the risk of veus thromboembolism in hospital patients. Updated Reducing the Risk of Veus Thromboembolism during Pregnancy and the Puerperium (Green-top Guideline No. 37a) April Summary of Product Characteristics and Patient Information Leaflets via Royal Marsden Manual of Clinical Nursing Procedures 8 th edition. Chapter 13 Perioperative Care. Antiembolism stockings and prophylactic anticoagulation Veus Thromboembolism (VTE) Risk assessment. NHS England VTE Prevention England. Website of the National VTE Prevention Program Kings College Hospital risk assessment for Veus Thromboembolism. King s thrombosis Team HAT & UKCPA Q&A What doses of thromboprophylaxis are appropriate for adult patients at extremes of body weight? June 2015 via NHS Evidence 13. Appendices 1 Department of Health VTE Risk Assessment [EPMA] 2 Surgical / Orthopaedic Risk Assessment Tool 3 Medical Admissions Flow Chart 4 Mechanical VTE prophylaxis 5 Pharmacological VTE prophylaxis 6 Orthopaedic THR TKR dabigatran guide 7. Financial and Resourcing Impact Assessment on Policy Implementation 8. Equality Impact Assessment Tool Version No. 4.0 Page 10 of 22

11 Department of Health/NICE CG92 VTE Risk Assessment [EPMA] Appendix 1 RISK ASSESSMENT FOR VENOUS THROMBOEMBOLISM (VTE) Initial assessment (tick as appropriate)[ ] Re-assessment within 24 hours [ ] Within 72 hours of admission [ ] Due to a change in clinical situation [ ] ]]]]]] Mobility ] ] All patients (tick one box) Tick Tick Tick Surgical patient Medical patient expected to have ongoing reduced mobility relative to rmal state Assess for thrombosis and bleeding risk below Medical patient NOT expected to have significantly reduced mobility relative to rmal state Risk assessment w complete Thrombosis Risk Patient related Tick Admission related Tick Active cancer or cancer treatment Significantly reduced mobility for 3 days or more Age > 60 Hip or knee replacement Dehydration Hip fracture Kwn thrombophilia s Total anaesthetic + surgical time > 90 minutes Obesity (BMI >30 kg/m 2 ) Surgery involving pelvis or lower limb with a total anaesthetic + surgical time > 60 minutes One or more significant medical co-morbidities Acute surgical admission with e.g. 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 Use of oestrogen-containing contraceptive therapy Varicose veins with phlebitis Pregnancy or < 6 weeks post-partum (see NICE guidance for specific risk factors) inflammatory or intra-abdominal condition Critical care admission Surgery with significant reduction in mobility Bleeding Risk: Any tick should prompt clinical staff to consider if bleeding risk is sufficient to preclude pharmacological intervention Patient related Tick Admission related Tick Active bleeding Neurosurgery, spinal surgery or eye surgery Acquired bleeding disorders (such as acute liver Other procedure with high bleeding risk failure) Concurrent use of anticoagulants kwn to increase the risk of bleeding (such as warfarin with INR >2) Lumbar puncture/epidural/spinal anaesthesia expected within the next 12 hours Untreated inherited bleeding disorders (such as haemophilia and von Willebrand s disease) Lumbar puncture/epidural/spinal anaesthesia within the previous 4 hours Thrombocytopaenia (platelets< 75x10 9 /L) Acute Stroke Uncontrolled systolic hypertension (230/120 mmhg or higher) Version No. 4.0 Page 11 of 22

12 Appendix 2 Surgical / Orthopaedic Thromboprophylaxis Risk Assessment Tool for n-pregnant patients over the age of 18 undergoing surgery requiring an in-patient stay. Seek advice if on an oral anticoagulant e.g. WARFARIN or a NOAC See separate guidance for patients for elective total hip (THR) or knee replacement (TKR) surgery Identification of risk (tick all that apply) General risk factors Common medical risk factors Age >60years Obesity (BMI>30kg/m²)) Established or expected post-op immobility Dehydration Sepsis Cancer Continuous travel >3hours within 4 weeks before or after surgery Pregnancy (seek advice) or <6 weeks post-partum Use of oestrogen containing contraceptive or HRT (consider stopping) Varicose veins associated with phlebitis Central veus line in-situ Surgery >30 minutes Major lower limb surgery (High Risk)* Acute medical illness Active cardiac or respiratory failure MI or stroke within 12 months Inflammatory bowel disease Personal or 1 st degree family history of VTE (High Risk)* Rarer medical risk factors Antiphospholipid syndrome Behcet s disease Myeloproliferative disease Nephrotic syndrome Paraproteinaemia Paroxysmal cturnal haemoglobinuria Inherited thrombophilia (High Risk)* Treatment according to risk level: Low risk: No risk factors Early ambulation Antiembolism stockings Moderate risk: 1-2 risk factors Early ambulation Antiembolism Stockings High risk:* CONTRAINDICATIONS Exaparin Antiembolism stockings or Intermittent pneumatic calf compression 3 or more risk factors Or any High Risk factor In addition consider Haemorrhagic disorders or active bleeding Thrombocytopenia Active Peptic ulceration Severe uncontrolled hypertension CA or head injury within last 3 months Hypersensitivity to heparin Severe liver disease Severe renal failure (creatinine> 200) Surgeon assesses high risk of haemorrhage Peripheral vascular disease Diabetic neuropathy Stockings t tolerated Exaparin 20mg sc 1800hrs until fully ambulant Early ambulation Antiembolism stockings Intermittent pneumatic calf compression Exaparin 20mg sc until fully ambulant. Increasing exaparin dose to 40mg Extending prophylaxis for 4 weeks following surgery Risk level: Assessed by: Date: Prophylaxis prescribed: Version No. 4.0 Page 12 of 22

13 VTE Risk Assessment for Medical patients Appendix 3 Medical patients including patients with stroke, cancer or central veus catheters. Is the patient expected to have significantly reduced mobility relative to rmal state? No Carry out full VTE and bleeding risk assessment Do t routinely offer prophylaxis. Reassess within 24 hours of admission and whenever clinical situation changes Does risk of bleeding outweigh risk of VTE or is pharmacological prophylaxis contraindicated? No Offer exaparin or heparin as per renal function. Continue until patient is longer at increased risk of VTE Has patient been admitted for Stroke? No Yes Do t offer Anti Embolism Stockings for VTE prophylaxis Consider offering mechanical VTE prophylaxis with: AES and or IPC or foot impulse devices Reassess VTE and bleeding risk within 24hours of admission and whenever clinical situation changes Does patient have major restriction of mobility, previous history of VTE, dehydration or comorbidity (e.g. malignant disease)? No Yes Haemorrhagic stroke excluded? Yes No Consider offering foot impulse or intermittent pneumatic compression device until patient can have pharmacological VTE prophylaxis Risk of bleeding (haemorrhagic transformation of stroke or bleeding into ather site) low? No Yes Consider offering exaparin or heparin as per renal function When acute event is over and patient s condition is stable Stop pharmacological prophylaxis Version No. 4.0 Page 13 of 22

14 Integrated VTE management plan for all Medical Admissions Department of Health VTE Risk Assessment Tool Moderate/High Risk No contraindications to Thrombopropylaxis LMWH prescribed Yes / No If No state reason.... Antiembolism stockings Yes / No Signature (Exaparin 20mg if egfr<30) Version No. 4.0 Page 14 of 22

15 Appendix 4 Mechanical VTE prophylaxis Antiembolism Stockings (AES) Staff who fit stockings must be trained in their use. Antiembolism stockings (AES) should be offered to patients as a first line option unless they are contraindicated. All patients should be offered intermittent pneumatic compression during the intra-operative period unless contraindicated and these should continue on the ward if possible Staff who fit stockings should be trained to measure and fit the correct stocking size. This size should be formally documented in the patients ted. (If a patient develops oedema or postoperative swelling develops ensure legs are re-measured and stockings refitted if appropriate). If arterial disease suspected, seek a vascular opinion before applying stockings. Stockings should be worn day and night from admission until they longer have significantly reduced mobility. Remove stockings daily for hygiene purposes and to inspect the skin condition. If the patient has defective skin integrity, significantly poor mobility or sensory loss, inspect skin at least twice daily, particularly over heels and bony prominences in order to pick up any emerging secondary problems. Cease use of stockings (and reassess VTE risk management) if there are new skin changes or new loss of skin integrity, particularly over heels and bony prominences. or If a patient is unable to tolerate AES due to discomfort or pain, reassess VTE risk and provide an alternative preventative measure. Demonstrate to patients how to wear antiembolism stockings correctly and ensure they understand that this will reduce their risk of developing VTE. In the case of amputation consider fitting AES to unaffected limb. Contraindications to AES Acute stroke Peripheral neuropathy or other causes of sensory impairment. Peripheral arterial bypass grafting. Allergic reaction to the material of the stockings. Suspected or proven peripheral arterial disease. Skin fragility or recent skin grafting. Severe leg oedema. Pulmonary oedema due to congestive heart failure. Atypical leg size or shape or deformity. Major limb deformity preventing correct fit. Use caution and clinical judgment when applying AES over veus ulcers or wounds and inspect and review regularly. Foot impulse and intermittent pneumatic compression devices (IPC) Encourage patients on the ward who have these devices to use them as much possible and when in bed and when sitting in a chair. However, early mobilisation is recommended (as appropriate). Contraindications Confirmed acute DVT or PE and contraindications as for AES above. Version No. 4.0 Page 15 of 22

16 Appendix 5 Pharmacological prophylaxis Exaparin [Clexane SPC] and Heparin [See separate Maternity Unit Guidelines for use in pregnancy & puerperium] Exaparin: The recommended dose of exaparin is 40 mg (4,000 IU) once daily by subcutaneous (sc) injection for medical patients and surgical patients at higher risk. In patients at low to moderate risk the dose is 20mg once daily. Exaparin and unfractionated heparin dosing in renal impairment Mild or renal impairment (egfr > 30mL/min/1.73m2) exaparin 40mg once daily. Moderate renal impairment (egfr 15-30mL/min/1.73m2) exaparin 20mg once daily. Severe renal impairment (egfr < 15mL/min/1.73m2) heparin 5000units sc twice daily. Extremes of Body Weight: There is consensus on exaparin dose adjustment. In low-weight women (< 45 kg) or men (< 57 kg) there may be higher risk of bleeding; monitor closely, consider 20mg once daily. Obesity is a risk factor for VTE. Consider increasing dose to 40mg twice daily in the extremely obese >100kg patient. (14) Patients with increased bleeding risk Clinicians may consider exaparin 20mg once daily for patients with bleeding risk and significant VTE risk. Rapid reversal of Exaparin if bleeding occurs Administer 40mg protamine sulphate given slowly at 5mg/min (up to 1mg protamine per 1mg exaparin given, to a maximum of 50mg as per BNF) for partial reversal. Note risk of anaphylaxis, if previously exposed to protamine or protamine insulin give pretreatment with antihistamine and steroids. Avoid in shellfish allergy. This may need to be repeated due to the continuous absorption of exaparin. Seek Haematologist advice. Note the amount of exaparin in the body drops to 50% after 8hours. Extended pharmacological VTE prophylaxis Patients requiring extended prophylaxis should be identified in pre-assessment or at the time of admission. The extended regimen should be indicated in the medical tes and on the drug treatment record. Extended prophylaxis should be offered to patients after major cancer surgery in the abdomen or pelvis, total hip or knee replacement, or hip fracture (including #NOF) or other patients at high VTE risk. Timings for Epidurals/Spinals and Neurological patients - Exaparin: Intraspinal haematoma may cause paralysis. INSERTION or REMOVAL of an epidural/spinal catheter should be delayed for at least 12 hours after administration of prophylactic doses of exaparin; consider delaying for up to 24hours in severe renal impairment. Do t administer exaparin for at least 4 hours AFTER spinal/epidural catheter REMOVAL Exaparin should t be administered for at least 12 hours after insertion of external ventricular drains, spinal drains or intracranial pressure monitors Version No. 4.0 Page 16 of 22

17 Monitoring Exaparin and unfractionated heparin treatment Check baseline platelet count before the initiation of therapy, at days 5 and 10 and then once again between days of treatment. If platelets fall by more than 30% of baseline stop heparin treatment and discuss with haematology. Monitor renal function and adjust dose accordingly. Consider potassium monitoring especially in those susceptible or patients predisposed to hyperkalaemia as heparins may cause hypoaldosteronism. At doses used for prophylaxis, exaparin does t influence global blood coagulation tests such as APTT and prothrombin time significantly. Fondaparinux Fondaparinux 2.5mg sub-cutaneous injection once daily may be considered where the use of a porcine derived low molecular weight heparin is contraindicated on grounds of religious belief. Fondaparinux should t be used in patients with creatinine clearance <20 ml/min. Reduce to 1.5 mg once daily in patients with creatinine clearance in the range of 20 to 50 ml/min. Use with caution in patients with HIT. See SPC [Arixtra] for full information Version No. 4.0 Page 17 of 22

18 Orthopaedic VTE Prophylaxis Guideline Dabigatran For Elective Total Hip and Total Knee Replacement surgery 1) Elective Hip Replacement 2) Elective Knee Replacement Preadmission VTE risk assessment Preadmission VTE risk assessment At Admission reassess At Admission reassess If t contraindicated, offer mechanical VTE prophylaxis with If t contraindicated, offer mechanical VTE prophylaxis with one of Foot Pumps or Intermittent pneumatic compression device Foot pumps or Intermittent pneumatic compression device Antiembolism stockings Antiembolism stockings Continue until patient s mobility is longer significantly reduced Continue until patient s mobility is longer significantly reduced Encourage early mobility within 24hours as per ERAS programme Encourage early mobility within 24hours as per ERAS programme Appendix 6 On the day following surgery at 1800hours Provided contraindications* and haemostasis has been obtained commence oral prophylaxis with dabigatran 150mg daily (2x75mg) and continue to total duration of 30 (28-35) days. If Patient <75 years, with CrCl >50ml/min, AND ONLY on the advice of the Senior Consultant Surgeon, consider offering dabigatran 220mg daily (2x110mg) for a total duration of 30 (28-35) days On the day following surgery at 1800hours Provided contraindications* and haemostasis has been obtained commence oral prophylaxis with dabigatran 150mg daily (2x75mg) and continue to a total duration of 10 days. If Patient <75 years, with CrCl >50ml/min, AND ONLY on the advice of the Senior Consultant Surgeon, consider offering dabigatran 220mg daily (2x110mg) for a total duration of 10 days CONTRAINDICATIONS to dabigatran* (See Pradaxa SPC for full information) Patients with severe renal impairment (CrCL< 30 ml/min) Active clinically significant bleeding Lesion or condition considered a significant risk factor for major bleeding e.g. gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury or ophthalmic surgery, recent intracranial haemorrhage, kwn or suspected oesophageal varices, vascular aneurysms or abrmalities (See SPC) Concomitant treatment with any other anticoagulants Hepatic impairment or liver disease Concomitant treatment with ketoconazole, ciclosporin, itraconazole, dronedarone, tacrolimus Prosthetic heart valves requiring anticoagulant treatment CAUTIONS: Spinal epidural or lumbar puncture. Start dabigatran at least 2hours after cannula removal Antiplatelet agents, aspirin, SSRIs, NSAIDs, amiodarone. Gastro-oesophageal disease Rifampicin, St John s wort, carbamazepine, phenytoin- reduced efficacy Note these guidelines may lie outside the Pradaxa product licence Version No. 4.0 Page 18 of 22

19 Appendix 7 Financial and Resourcing Impact Assessment on Policy Implementation Resources are already deployed and the introduction of this policy will have further resourcing impact. Version No. 4.0 Page 19 of 22

20 Appendix 8 Equality Impact Assessment (EIA) Screening Tool Document Title: Purpose of document Target Audience To reduce the risk of a patient developing VTE whilst under the care of the Isle of Wight NHS Trust All clinical staff Person or Committee undertaken the Equality Impact Assessment 1. To be completed and attached to all procedural/policy documents created within individual services. 2. Does the document have, or have the potential to deliver differential outcomes or affect in an adverse way any of the groups listed below? If confirm underneath in relevant section the data and/or research which provides evidence e.g. JSNA, Workforce Profile, Quality Improvement Framework, Commissioning Intentions, etc. If yes please detail underneath in relevant section and provide priority rating and determine if full EIA is required. Positive Impact Negative Impact Reasons Gender Race Men Women Asian or Asian British People Black or Black British People Chinese people People of Mixed Race White people (including Irish people) People with Physical Version No. 4.0 Page 20 of 22

21 Sexual Orientat ion Age Disabilities, Learning Disabilities or Mental Health Issues Transgender Lesbian, Gay men and bisexual Children Older People (60+) Younger People (17 to 25 yrs) n/a Does t cover Paediatric Services Faith Group Pregnancy & Maternity Equal Opportunities and/or improved relations Notes: n/a n/a See Separate Maternity Unit Guidelines Faith groups cover a wide range of groupings, the most common of which are Buddhist, Christian, Hindus, Jews, Muslims and Sikhs. Consider faith categories individually and collectively when considering positive and negative impacts. The categories used in the race section refer to those used in the 2001 Census. Consideration should be given to the specific communities within the broad categories such as Bangladeshi people and the needs of other communities that do t appear as separate categories in the Census, for example, Polish. 3. Level of Impact If you have indicated that there is a negative impact, is that impact: Legal (it is t discriminatory under anti-discriminatory law) YES NO Intended If the negative impact is possibly discriminatory and t intended and/or of high impact then please complete a thorough assessment after completing the rest of this form. 3.1 Could you minimise or remove any negative impact that is of low significance? Explain how below: Include option of fondaparinux in VTE prophylaxis 3.2 Could you improve the strategy, function or policy positive impact? Explain how below: 3.3 If there is evidence that this strategy, function or policy promotes equality of opportunity or Version No. 4.0 Page 21 of 22

22 improves relations could it be adapted so it does? How? If t why t? Scheduled for Full Impact Assessment Name of persons/group completing the full assessment. Date Initial Screening completed Date: Version No. 4.0 Page 22 of 22