Anticoagulation and Thromboprophylaxis Policy

Transcription

1 Anticoagulation and Thromboprophylaxis Policy Controlled document This document is uncontrolled when downloaded or printed Reference number Version 6 Author WHHT: C035 Gail Abrahamson Date ratified September 2014 Committee: Quality & Safety Group Issue date August 2014 Review date August 2017 Target audience Key Words Previous Policy Name All Clinicians Anticoagulation, Warfarin, Heparin, Thromboprophylaxis. VTE A Policy on Anticoagulation and Thromboprophylaxis Author: Gail Abrahamson Review Date: September 2017 Page 1 of 73

2 CONTENTS 1. Change History 3 2. Background and Introduction 3 3. Purpose 3 4. Duties and responsibilities 3 5. Teaching and Training 4 6. Process for monitoring compliance and effectiveness 4 7. Glossary 4 8. References 5 Appendices: 1 Guidance Notes for Thromboprophylaxis in Adult Medical, Surgical and Day cases 2 Risk Assessment Form for Venous Thromboembolism (VTE) in Adults 9 3 Thromboprophylaxis in Adult Obstetric Patients 12 4 Low Molecular Weight Heparin (LMWH) Enoxaparin for venous thromboembolism and acute coronary syndrome 5 Protocol for Anticoagulation using Unfractionated Heparin 16 6 Anticoagulation using Warfarin Induction dosage chart for venous thrombosis Induction dosage chart for atrial fibrillation Dosage maintenance and monitoring Management of Surgery in patients on Warfarin (including Implantation of Permanent Pacemakers/Intracardiac Devices) Flowchart for high risk patients requiring bridging Flowchart for patient not requiring bridging Reversal of excessive anticoagulation with Warfarin Discharge of inpatients taking Warfarin Documentation for patients on Warfarin 7 Referral to Anticoagulant clinic 49 8 Information to be discussed with the patient when starting warfarin 50 9 Switching between the new oral anticoagulants (NOACs) and warfarin Management of New Oral Anticoagulants (NOACs) in Patients having elective surgery where there is a risk of bleeding 11. Local decisions on Anticoagulants Procedure to be followed if venous thromboembolism is suspected Assessment of patient with DVT for Rivaroxaban Reversal of Dabigatran associated bleeding Reversal of Rivaroxaban associated bleeding Initial management of acute coronary syndrome Guidelines on the use of Fondaparinux for treatment of adults withunstable antina (UA) and non-st segment elevation myocardial infarction (NSTEMI) 18. Anticoagulation for continuous veno-venous haemodiafiltration guideline 64 Page Author: Gail Abrahamson Review Date: September 2017 Page 2 of 73

3 Change History Version Date Author Reason Ratification required 6 Aug 2014 Gail Abrahamson Major Policy review Yes 5.11 Oct 2013 Gail Abrahamson Amendment to Appendix 6 No 5.10 July 2013 Gail Abrahamson Revisions to Appendix 6 No 5.9 Nov 2012 Fatts Chowdhury Revisions to Appendix 6 Extension to review date No (DTC approved 11/12) 5.8 June 2012 Gail Abrahamson Revisions to Appendix 1 No (DTC approved 06/12) 5.7 Sep 2011 Gail Abrahamson New appendix 11 No (Fondaparinux) 5.6 May 2011 Gail Abrahamson New appendices 5 &10, plus amendment to VTE risk assessment form (DTC approved 09/11) No 5.5 Mar 2011 Gail Abrahamson Amendment to Appendix 2 Yes 5.4 Feb 2011 Gail Abrahamson Revisions to Appendix. 4 Yes 5.3 Oct 2010 Gail Abrahamson Policy revision Yes 4 Jun 2008 Paul Hart, Liz Gaminara Policy revision Yes 1. Background and Introduction Venous thromboembolism (VTE) is both a preventable and treatable condition. To date, the management of VTE, particularly thromboprophylaxis, has been poor and it remains responsible for approximately 25,000 deaths in England each year. In addition, there is significant clinical risk associated with anticoagulation, the treatment of choice for VTE once it has occurred. As a result of these ongoing problems, the Chief Medical Officer, advised by an Independent Expert Working Group, requires trusts to introduce processes to ensure that all hospital inpatients have a mandatory thromboprophylaxis risk assessment. Appropriate prophylaxis should be given for patients falling into the highrisk groups. In addition, the NPSA has published guidance and standards designed to optimize on going treatment with anticoagulants both for in patients and for out patients. Compliance with these standards is to be monitored through a programme of regular audit. The enclosed protocols are based on a large body of evidence which ranges from Grade A level Ia through to Grade C level iv and which is captured in a tranche of National Guidance which is detailed in the Reference section. 2. Purpose This is to reduce the incidence of VTE in hospital inpatients as well as to improve the safety/efficacy of treatment for those patients who do require anticoagulation. In order to achieve this, this policy provides information to healthcare professionals to ensure that all hospital inpatients are properly assessed for their risk of VTE and where appropriate, prophylaxis is implemented. It also describes optimal treatment (anticoaguiation) for those patients who develop VTE 3. Duties and Responsibilities It is the responsibility of the Thrombosis and Anticoagulant Advisory Panel (TAP) to ensure that the Trust protocols are evidence based, in line with National Guidance and up to date. It is also responsible for implementing an ongoing programme of education for all relevant health care professionals in WHHT. Author: Gail Abrahamson Review Date: September 2017 Page 3 of 73

4 Senior Clinicians are responsible for ensuring that all staff, particularly junior doctors, preop assessment staff and non-medical prescribers, keep up to date and implement the trust policy and clinical protocols. Junior doctors are responsible for implementing the protocols for all patients both as inpatients and on discharge. Nursing staff are responsible for facilitating the implementation of the protocols and in some cases (the pre-operative assessment team) will also undertake thromboprophylaxis risk assessment. 5. Teaching and Training Training requirements are outlined in the Training Needs Analysis. 6. Process for Monitoring Compliance and Effectiveness Audit. There will be an ongoing programme of audit which will include those recommended by the NPSA. Results will be reviewed on a regular basis by the TAP committee. Presentations will be made at Clinical Governance meetings as appropriate. Critical Incidents will be documented through the trust Datix system and the anticoagulant system (DAWN) and will be reviewed by TAP and at the Combined Anticoagulant Group meetings on a regular basis. 7. Glossary DVT PE VTE Thromboprophylaxis Anticoagulation Warfarin Heparin Unfractionated Heparin Low Molecular Weight Heparin Fondaparinux NOAC Deep Vein Thrombosis. Thrombosis in the deep veins of the legs Pulmonary Embolus. Thrombosis that has broken off from the veins of the legs and become logged in the vessels of the lungs Venous Thromboembolism. Includes DVT and PE Measures taken to reduce the risk of developing VTE Treatment to reduce the tendency of the blood to form clots in the veins An anticoagulant treatment in tablet form. An anticoagulant treatment in injectable form. To be injected into veins To be injected under the skin An anticoagulant in injectable form New oral anticoagulant Author: Gail Abrahamson Review Date: September 2017 Page 4 of 73

5 9. References a. Guidelines on oral anticoagulation: third edition. British Journal of Haematology 1998,101, b. Guidelines on oral anticoagulation:third edition. British Committee for Standards in Haematology 2005 c. Recommendations from the British Committee for Standards in Haematology and National Patient Safety Agency. British Journal of Haematology, , d. Prevention of Venous Thromboembolism, American College of Chest Physicians. Chest, ,338S-400S e. The Prevention of venous Thromboembolism in Hospitalised patients. House of Commons Health Committee.Feb 2005 f. Report of the independent working group on the prevention of venous thromboembolism in hospitalised patients. To Sir Liam Donaldson Chief Medical Officer 2006 g. NICE Clinical Guideline 46 April 2007 Venous Thromboembolism. Reducing the risk of venous thromboembolism in inpatients undergoing surgery. h. NICE Clinical Guideline 92 January 2010 Reducing the risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in patients admitted to hospital. i. Guidelines on oral anticoagulation with warfarin fourth edition. British Journal of Haematology guidelines Author: Gail Abrahamson Review Date: September 2017 Page 5 of 73

6 Appendix 1 Guidance Notes for Thromboprophylaxis in Adult Medical, Surgical in-patients and Day Cases All medical, surgical and obstetric inpatients and surgical day cases should be considered for thromboprophylaxis and a formal risk assessment of thrombotic and bleeding risk should be carried out on admission or in the preoperative assessment clinic. The generic WHHT risk assessment form Risk assessment for venous thromboembolism (VTE) in adults (see appendix 2) should be used except for obstetric patients. Exclusions: The following day case procedures are excluded from this requirement: Haemodialysis Endoscopy Helen Donald Unit chemotherapy patients Ambulatory Care Clinical Decision Unit Cardiac Catheter Laboratory Ophthalmological procedures with local anaesthetic/regional/sedation and not full general anaesthetic 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 Non-cancer dental and maxillo-facial surgery lasting less than 90 minutes with local anaesthetic/regional/sedation and not full general anaesthetic Other similar minor procedures lasting less than 90 mins with local/regional sedation and not full general anaesthetic Obstetric patients: There is a separate form and separate guidance for obstetric patients. Actions once risk assessment form has been completed: The completed risk assessment form should be kept in the medical record The ensuing management plan should be clearly documented in the medical record Once the appropriate methods of prophylaxis have been identified, they should be prescribed on the drug chart (low molecular weight heparin, unfractionated heparin, and anti-embolic stockings) or the operation sheet (other mechanical methods). N.B.:- 1. MEDICAL PATIENTS: it is extremely important that thromboprophylaxis is written up and administered on the day of admission. 2. Mechanical and chemical thromboprophylaxis must be prescribed separately Before starting prophylaxis, patients should be offered verbal and written information on: - risks and possible consequences of VTE - importance of VTE prophylaxis and its possible side-effects - correct use of mechanical methods of prophylaxis - how to reduce their risk of VTE (keeping well hydrated and, if possible, exercising) (See patient information leaflet) Author: Gail Abrahamson Review Date: September 2017 Page 6 of 73

7 As part of the discharge plan, patients should be given verbal and written information on: - signs and symptoms of deep vein thrombosis and pulmonary embolism - correct and recommended duration of use of VTE prophylaxis at home (if discharged with prophylaxis) - importance of using VTE prophylaxis correctly and continuing treatment for the recommended duration - signs and symptoms of adverse events related to prophylaxis - importance of seeking help and who to contact if they have any problems using prophylaxis - importance of seeking medical help and who to contact if deep vein thrombosis or pulmonary embolism is suspected (See patient information leaflet) Reassesment: Risk assessment must be repeated after 24 hours and whenever the patient s condition changes ADDITIONAL NOTES Enoxaparin dose and renal impairment Cr Cl < 30ml/min- use enoxaparin 20mg daily Enoxaparin dose and obesity Weight kg use enoxaparin 40mgbd. Weight > 150 kg- use enoxaparin 60mg bd Duration; extended prophylaxis Continue until mobility no longer significantly reduced. High risk orthopaedic patients should receive prophylaxis for at least 10 days. Extended prophylaxis (28 days) is recommended for elective hip replacement, hip fracture and other selected high risk patients eg major cancer surgery in the abdomen and pelvis. Stroke All patients with stroke must be formally risk assessed on admission. Graduated compression stockings should NOT be used in any patient with stroke as they are ineffective and may be harmful. Patients may be considered for intermittent mechanical compression when this is available. Haemorrhagic stroke: these patients should NOT receive heparin of any sort. Infarct: patients must be assessed on an individual basis. Those with large infarcts should not receive heparin for several days because of the high risk of haemorrhagic transformation. The patient should be formally reassessed on a daily basis as it may be appropriate to introduce lmwh at some point. Patients previously on Warfarin Patients who are already anticoagulated and require surgery should have their Warfarin and INR reduced according to the relevant protocols prior to admission. If this has not occurred, discuss with the haematologist. On admission the INR should be checked. If > 1.5 no chemical prophylaxis is required. If < 1.5, the risk assessment should be carried out and prophylactic Enoxaparin given according to protocol. As soon as the INR rises above 1.5 the Enoxaparin can be discontinued. Author: Gail Abrahamson Review Date: September 2017 Page 7 of 73

8 Patients receiving IV heparin Prophylactic Enoxaparin is not required in those patients receiving IV heparin, e.g.: during some forms of vascular surgery patients with a high thrombotic risk transferred from warfarin to peri-operative heparin. Anti-platelet medication Should be discontinued 7 10 days before elective surgery unless there are clinical indications to continue (see surgical protocols) Restart as soon as haemostasis has been achieved. The combined oral contraceptive pill and HRT Other May be stopped at least one month pre-operatively If stopped alternative methods of contraception should be recommended. May be continued if preferred, in which case the appropriate thromboprophylaxis risk assessment and management plan should be implemented In the presence of severe infection, haematological disorders, severe liver/renal disease or other anxiety, liaise with the appropriate clinical team. If there are patient concerns about using animal products it may be necessary to consider alternative thromboprophylaxis Author: Gail Abrahamson Review Date: September 2017 Page 8 of 73

9 Appendix 2 RISK ASSESSMENT FOR VENOUS THROMBOEMBOLISM (VTE) IN ADULTS All patients should be risk assessed on admission to hospital. Patients should be reassessed within 24 hours of admission and whenever the clinical situation changes All medical, surgical, obstetric inpatients and day cases should be considered for thromboprophylaxis. A formal risk assessment of thrombotic (VTE) and bleeding risk should be carried out on admission or in the Pre operative assessment clinic. Obstetric patients- see separate form Exclusions tick relevant box if appropriate: Haemodialysis Endoscopy Ambulatory Care Clinical Decision Unit Helen Donald Unit Chemotherapy Cardiac Cath lab Ophthalmological procedures with local anaesthetic/regional/sedation and not full general anaesthetic 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 Non-cancer dental and maxillo-facial surgery lasting less than 90 minutes with local anaesthetic/ regional/sedation and not full general anaesthetic Other similar minor procedures lasting less than 90 mins with local/regional sedation and not full general anaesthetic STEP ONE Assess all patients admitted to hospital for level of mobility (tick one box). STEP TWO Review the patient-related factors shown on the assessment sheet against thrombosis risk, ticking each box that applies (more than one box can be ticked). Any tick for thrombosis risk indicates HIGH risk of VTE, refer to page 3 of this form and also the WHHT Anticoagulation and thromboprophylaxis guidelines If no box is ticked for thrombosis risk, the patient is at low risk of VTE. The risk factors listed are not exhaustive; clinicians may consider additional risks in individual patients and offer thromboprophylaxis. STEP THREE Review the patient-related factors shown against bleeding risk and tick each box that applies (more than one box can be ticked). Any tick should prompt clinical staff to consider if bleeding risk is sufficient to preclude pharmacological intervention. STEP FOUR Date and sign risk assessment form Prescribe thromboprophylaxis in accordance with WHHT guideline for thromboprophylaxis following VTE risk assessment. Author: Gail Abrahamson Review Date: September 2017 Page 9 of 73

10 STEP ONE Surgical Tick patient Medical patient expected to have ongoing reduced mobility. MOBILITY - all patients (tick one box) Tick Medical patient NOT expected to have significantly reduced mobility. Tick Excluded patient Tick Assess thrombosis (VTE) and bleeding risk (STEP TWO AND THREE) Risk assessment now complete STEP TWO THROMBOSIS (VTE) 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 Known thrombophilias Total anaesthetic + surgical time > 90 minutes Obesity (BMI > 30 kg/m ) Surgery involving pelvis or lower limb with a total anaesthetic + surgical time > 60 minutes One or more significant medical comorbidities Acute surgical admission with inflammatory or intra-abdominal condition (e.g heart disease; metabolic, endocrine or respiratory pathologies; acute infectious diseases; inflammatory conditions) Personal history or first-degree relative Critical care admission with a History of VTE Use of hormone replacement therapy Surgery with significant reduction in mobility Use of oestrogen-containing contraceptive therapy NONE Varicose veins with phlebitis Pregnancy or up to 6 weeks post partum (see separate obstetric guidance) STEP THREE BLEEDING RISK 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 known to increase the risk of bleeding (such as Warfarin with INR >2, NOACs eg rivaroxaban, dabigatran) Lumbar puncture/epidural/spinal anaesthesia expected within next 12 hours Acute stroke (see Risk Assessment Guidance notes in Appendix to Anticoagulation Policy) Platelets <75 x 10 9 /l, check on admission Uncontrolled hypertension (230/120 mmhg or higher) Untreated inherited bleeding disorders (such as haemophilia and von Willebrand s disease) Preoperative assessment date: Name: Signed: Assessment to be confirmed by doctor on admission Lumbar puncture/epidural/spinal anaesthesia within previous 4 hours NONE On admission, date/time: Name: Signed: Author: Gail Abrahamson Review Date: September 2017 Page 10 of 73

11 STEP FOUR High Risk of VTE with low risk of bleeding Tick (1 or more ticks in Step 2, no tick in Step 3) RISK OF VTE High Risk of VTE with significant risk of bleeding (1 or more ticks in Step 2, 1 or more ticks in Step 3) Low risk of VTE Tick (No ticks in Step 2) Tick SURGICAL PATIENTS MEDICAL PATIENTS Risk of VTE Recommended prophylaxis Recommended prophylaxis HIGH risk of VTE with low risk of bleeding HIGH risk of VTE with significant risk of bleeding Enoxaparin 40 mg daily* + Anti-embolic stockings +/- sequential compression device (SCD) + Early mobilisation Anti-embolic stockings +/- sequential compression device (SCD) + Early mobilisation Enoxaparin 40 mg daily * (must be written up and given on the day of admission) + Early mobilisation Anti-embolic stockings +/- sequential compression device (SCD) + Early mobilisation (Do NOT use anti-embolic stockings in stroke patients) LOW risk of VTE Early mobilisation Early mobilisation Policy OBSTETRIC PATIENTS refer to Obstetric guidance in Appendix to Anticoagulation Neurosurgical patients Major head injury/neurosurgical patients Anti-embolic stockings Add enoxaparin only if decision documented by registrar/consultant CONTRAINDICATIONS Enoxaparin (CrCl <30ml/min use 20mg daily) Active bleeding Platelet count <75 Untreated inherited bleeding disorder Previous HIT or allergy to enoxaparin On therapeutic anticoagulation Acquired bleeding disorder Tick Anti-embolic stockings (AES)/SCDs Tick Severe peripheral vascular disease No SCDs if recent lower limb DVT(can use AES) Severe dermatitis Massive leg oedema Leg deformity Peripheral neuropathy Recent skin graft Allergy to fabric Stroke patients (do not use AES) Timing: Epidural/ of enoxaparin. Spinal Analgesia Duration: Enoxaparin should start 6 hours post op. In addition, Enoxaparin can be given the evening prior to surgery (excluding neurosurgery, see above). Mechanical VTE prophylaxis should be implementated at admission. MEDICAL patients: Enoxaparin must be written up and given on the day of admission. Placement or removal of catheter should be delayed for 12 hours after administration Enoxaparin should not be given sooner than 4 hrs after catheter removal. Continue until mobility no longer significantly reduced. High risk orthopaedic patients should receive prophylaxis for at least 10 days. Extended prophylaxis ( 28 days) is recommended for elective hip replacement, hip fracture and other selected high risk patients eg major cancer surgery in the abdomen and pelvis. *Obesity: Use Enoxaparin 40mg twice daily if body weight >100kg (or 60 mg bd if body weight > 150 kg Author: Gail Abrahamson Review Date: September 2017 Page 11 of 73

12 >150kg) Appendix 3 Policy for Thromboprophylaxis in Obstetric Patients Refer to RCOG Green-top 37 Guideline: Thrombosis and Embolism during Pregnancy and the Puerperium, reducing the risk (November 2009): Author: Gail Abrahamson Review Date: September 2017 Page 12 of 73

13 Appendix 4 Low Molecular Weight Heparin (LMWH) Enoxaparin for venous thromboembolism and acute coronary syndrome 1. Check the platelet count, baseline clotting screen and U+E 2. Ensure that the patient has been weighed, if necessary using a hoist 3. Re-weigh the patient during treatment if clinically indicated 4. Record the weight on the prescription chart 5. Record indication for treatment, weight and renal function in patient s notes. 6. The following may be treated as outpatients - confirm suitability: Uncomplicated DVT, proximal or distal Uncomplicated PE 7. Treatment regimens and dosage tables: Venous thromboembolism: Enoxaparin 1.5 mg/kg once daily sc to be given in the early evening. Dosage table - Enoxaparin 1.5 mg/kg once daily sc (a per the SPC for Clexane Forte) (use colour coded pre-filled syringes): Weight* (kg) Dose (kg) 60 mg sc once daily 67.5 mg sc once daily 75 mg sc once daily 82.5 mg sc once daily 90 mg sc once daily 97.5 mg sc once daily 105 mg sc once daily mg sc once daily 120 mg sc once daily mg sc once daily 135 mg sc once daily mg sc once daily 150 mg sc once daily Syringe to use 60 mg (orange) 80 mg (brown) 80 mg (brown) 100 mg (black) 100 mg (black) 100 mg (black) 120 mg (purple) 120 mg (purple) 120 mg (purple) 150 mg (blue) 150 mg (blue) 150 mg (blue) 150 mg (blue) Injection volume (ml) ) N.B. 1) 60 mg, 80 mg & 100 mg syringes contain 100 mg/ml solution for injection whereas the 120 mg & 150 mg syringes contain 150 mg/ml solution for injection. 2) *If the patient s weight falls between the values in the table, round up or down to the nearest 5kg Venous thromboembolism in pregnancy (unlicensed): Enoxaparin 1.0mg/kg twice daily sc based on booking or most recent body weight. Close liaison is necessary between the Obstetrician and Haematologists in all cases Non-ST-segment elevation (NSTE) acute coronary syndrome: Fondaparinux is now given in preference to low molecular weight heparin EXCEPT when: a) Wt <50 kg- give enoxaparin 1mg/kg bd sc b) egfr < 20ml/min- give enoxaparin 1mg/kg once daily sc It is given concurrently with aspirin (and clopidogrel). (See Cardiology protocol & Fondaparinux guidelines at Appendix 11 for details) Dosage table - Enoxaparin 1.0mg/kg twice daily sc (use colour coded pre-filled syringes): Weight* (kg) Dose (kg) Syringe to use Injection volume (ml) Author: Gail Abrahamson Review Date: September 2017 Page 13 of 73

14 mg sc twice daily 45 mg sc twice daily 50 mg sc twice daily 55 mg sc twice daily 60 mg sc twice daily 65 mg sc twice daily 70 mg sc twice daily 75 mg sc twice daily 80 mg sc twice daily 85 mg sc twice daily 90 mg sc twice daily 95 mg sc twice daily 100 mg sc twice daily 40mg (yellow) 60 mg (orange) 60 mg (orange) 60 mg (orange) 60 mg (orange) 80 mg (brown) 80 mg (brown) 80 mg (brown) 80 mg (brown) 100 mg (black) 100 mg (black) 100 mg (black) 100 mg (black) N.B. *If the patient s weight falls between the values in the table, round up or down to the nearest 5kg N.B: i) RENAL IMPAIRMENT If creatinine clearance <30ml/min, the dose must be reduced as follows: 1.5mg/kg once daily reduced to 1mg/kg once daily 1mg/kg twice daily reduced to 1mg/kg once daily (PLEASE NOTE the difference in renal thresholds for enoxaparin and fondaparinuxsee point 7) ii) ELDERLY PATIENTS In NSTE acute coronary syndromes, if patient 75 years reduce dose as follows: 1mg/kg twice daily reduced to 0.75mg/kg twice daily iii) MORBIDLY OBESE PATIENTS Patients who are morbidly obese (BMI>40 kg/m2) may be considered for anti-xa level monitoring after 48 hours and dose adjustment. Levels are performed within working hours and must be arranged in advance with the laboratory. Please discuss with haematologist. Anti Xa levels do not need to be monitored routinely in patients on low molecular weight heparin. 8. With treatment doses of enoxaparin there is no need for routine laboratory monitoring. Monitoring using anti Xa levels may be considered in patients with significant renal impairment, patients with recurrent VTE or those at the extremes of body weight. Please discuss with the Consultant Haematologist. 9. If the patient is to receive enoxaparin for more than 5 days the platelet count should be rechecked after 5 days in order to detect those patients who might develop heparin-induced thrombocytopenia. If the patient has previously been exposed to heparin within the past 100 days they should also have a platelet count performed before the second dose of enoxaparin. 10. Venous thromboembolism converting to warfarin In non-pregnant patients warfarin should be started as soon as a diagnosis of venous thromboembolism is confirmed and should be monitored daily using the INR. Warfarin must not be given for VTE in pregnant patients. LMWH should be continued until the post natal period, when conversion to warfarin can be considered. When the patient is receiving both warfarin and LMWH, it is practical to take blood samples for INR measurement first thing in the morning and to administer both the heparin and warfarin in the evening. It is sometimes necessary to give the LMWH early in the day before the INR is known. This is acceptable practice but warfarin should always be given in the evening. Author: Gail Abrahamson Review Date: September 2017 Page 14 of 73

15 Once the INR has been 2.0 for 2 consecutive days the LMWH (enoxaparin) should be discontinued. (Full anticoagulation is not achieved until all the vitamin K dependent factors have been depressed. This usually takes 3-5 days). If long-term anticoagulation is required the patient should be treated with warfarin. If this is not possible, LMWH (enoxaparin) can be used but it should be remembered that complications such as osteoporosis are dose related and duration of treatment should be kept to a minimum. N.B. Warfarin is not used in pregnancy except in exceptional cases and only following detailed discussion with a Consultant Haematologist. 11. It is the prescriber s responsibility to make sure that the following are clearly written on the transfer/discharge letter: indication for enoxaparin body weight date of initiation baseline renal function treatment schedule required duration Author: Gail Abrahamson Review Date: September 2017 Page 15 of 73

16 Appendix 5 PROTOCOL FOR ANTICOAGULATION USING UNFRACTIONATED HEPARIN Before starting heparin, coagulation screen and platelet count should be checked. HEPARIN LOADING DOSE - BOLUS - use Heparin 5000 units / 5 ml amps If APTT < 1.3, give 5000 units (5ml) over 5 minutes If Pt s weight is <50kg or >100kg give 80 units /kg If Pt >80 years, give 2,500 units (2.5ml) over 2.5 minutes HEPARIN INFUSION - use Heparin 20,000 units in 20ml amps = 1000 units in 1ml Initial Infusion Rate, give 1000 units / hr = 1ml / hr If pt >80 years, give 800 units / hr = 0.8ml / hr If pt s weight is <40kg or >100kg use infusion rate of 25units/kg/hr Monitor the heparin treatment using the APTT expressed as the Hep ratio. Aim to keep this at x normal. Do the first test 3 6 hours after starting treatment. Change the infusion rate (as per chart below) if necessary, guided by the Hep ratio. Intravenous Heparin Dose Adjustment Chart Hep ratio Action and dose change 1.3 Administer further IV loading dose of 5000 units Increase by 400 units/hr Administer further IV loading dose of 2500 units Increase by 200 units/hr Change in infusion rate Increase by 0.4 ml/hr Increase by 0.2 ml/hr Re-test hep ratio after (hours) No change No change Within 24 hours Stop infusion for 30mins Reduce by 100 units/hr >3.0 Stop infusion for 60mins Reduce by 500 units/hr Reduce by 0.1 ml/hr 6 Reduce by 0.5 ml/hr Warfarin may be started in the normal way, on the first or second day of Heparin. If Heparin is required for more than the initial 3-5 days, treatment with Warfarin may be delayed accordingly. The Heparin can be discontinued as soon as the Warfarin has become effective (INR > 2 on two consecutive days). This normally takes 3-5 days. The simultaneous use of Heparin and Warfarin does not preclude the monitoring of both drugs, the INR reflecting the effect of Warfarin and the Heparin ratio reflecting the effect of Heparin, as long as both remain in or below the therapeutic range. Reversal of the anticoagulant effect of Heparin is seldom required because of its short half life, unless the patient is actively bleeding or there is a need for urgent surgical intervention. Stop the Heparin, consider Protamine Sulphate, discuss with the Haematologist. The platelet count should be checked after 5 days on Heparin treatment in order to detect those patients who might develop Heparin induced Thrombocytopenia. If the patient has previously been exposed to heparin within the past 100 days they should also have a platelet count performed before the second dose of heparin. Author: Gail Abrahamson Review Date: September 2017 Page 16 of 73

17 Appendix 6 Anticoagulation using Warfarin Before starting anticoagulation Check FBC, U+E, LFTs and coagulation screen Indications & Contra-Indications Indications The prevention and treatment of venous and arterial thromboembolism. If the patient cannot take Warfarin (allergy or resistance) then the use of other anticoagulants should be discussed with the Consultant Haematologist. Contra-Indications: Absolute Active haemorrhage Ischaemic stroke in the absence of AF (or other cause of thromboembolism) Pregnancy Warfarin should only be used in exceptional cases and should always be avoided in the first trimester. Discuss management with the Haematologist Relative: The risk of haemorrhage is multifactorial and individual patients should be assessed accordingly, with the overall risk of haemorrhage balanced against the risk of withholding anticoagulation. The following factors should be given consideration: Extreme old age Confusion/inability/unwillingness to comply with instructions Alcohol abuse Uncompensated cirrhosis Chronic renal failure Uncontrolled hypertension Pre-existing haemostatic defect Oesophageal varices Active peptic ulcer Inflammatory bowel disease Recent surgery/trauma to CNS/eye The presence of vascular malformations Significant impairment of liver function Indications for Anticoagulation, target INR and duration 1. Venous Thromboembolic disease (VTE) First episode Introduce warfarin along with parenteral anticoagulation which should be continued for at least 5 days and until INR >or = 2.0 for at least 24 hours INR target 2.5 Range 2-3 Duration: PE or Proximal DVT Isolated calf vein DVT at least 3 months 6 weeks Author: Gail Abrahamson Review Date: September 2017 Page 17 of 73

18 Continuing beyond initial 3 month period: Consider for unprovoked proximal VTE or PE as strong predictor of recurrence Weigh up against risk of bleeding NOT recommended for calf vein DVT, or provoked VTE where transient risk factors Subtherapeutic INR ( <1.7) in first month of anticoagulation after acute VTE Consider bridging with low molecular weight heparin Arterial or venous thrombosis with Anti-phospholipid antibodies/lupus anticoagulant Target INR 2.5. No evidence to support a higher target. Cancer-related VTE Initial treatment - therapeutic lmwh ( superior to warfarin) for 6 months Recurrent VTE whilst anticoagulated and within therapeutic range Increase target INR to Atrial fibrillation (AF) INR Target 2.5 Range 2-3 Duration: long term 3. Patients with AF who are to have elective cardioversion Before procedure: Anticoagulate for at least 3 weeks. Target 3.0 to ensure > 2.5 on day. After procedure: 4. Valvular heart disease if sinus rhythm achieved and sustained anticoagulate for at least 4 weeks, Target 2.5 Mitral stenosis or regurgitation with AF, history of systemic embolism, left atrial thrombus or enlarged left atrium. Target Mechanical prosthetic heart valves Prosthesis INR target INR target Thrombogenicity* No pt risk factors Pt-related risk factors + Low Medium High *Low: aortic Carbomedics, Medtronic Hall, St Jude Medical Medium: Bjork-Shiley, other bileaflet. High: Starr-Edwards, Omniscience, Lillehei-Kaster + Mitral, tricuspid or pulmonary position. Previous arterial thromboembolism; atrial fibrillation; left atrial diameter >50mm; mitral stenosis; left atrial ejection fraction <35%; left atrial dense spontaneous echo contrast 6. Bioprosthetic heart valves Target 2.5 Mitral 3 months History of systemic embolism- at least 3 months Left atrial thrombus at surgery- until clot resolved Other prothrombotic risk factors eg AF, low ventricular ejection fraction Dilated cardiomyopathy Target INR 2.5 Author: Gail Abrahamson Review Date: September 2017 Page 18 of 73

19 7. Peripheral vascular disease Intermittent claudication- not required Acute arterial embolism proceeding to embolectomy - consider long-term, INR Myocardial infarction Warfarin not routinely used. When used, target INR Anticoagulation is not routinely recommended in the following circumstances where there is no evidence of benefit but which continue to be the subject of ongoing debate and clinical trials. The decision to anticoagulate in these situations will be based on individual patient characteristics and clinician preference. Mini dose Warfarin as surgical prophylaxis to protect central lines no evidence of benefit. Coronary angioplasty and stents (Aspirin and Clopidogrel recommended) Vena caval filters if Warfarin is used do individual risk benefit analysis. If Warfarin is used, target INR 2.5. Retinal vessel occlusion no studies on benefits of anticoagulation which should only be used in the context of the antiphospholipid syndrome 10. The role of anticoagulation in the management of stroke N.B. Please liaise with the stroke physicians TIAs should be treated with Aspirin +/- dipyridamole. There is no evidence that Warfarin is beneficial unless there is a cardiac source of embolus, in which case follow the appropriate guideline. The presence of carotid artery stenosis is not an indication for anticoagulation. Haemorrhagic stroke anticoagulation is contra-indicated. Ischaemic stroke in the absence of AF or mural thrombus, anticoagulation is contraindicated. Embolic/Ischaemic stroke in the presence of AF or mural thrombus defer anticoagulation for 48 hours to 14 days. Patients with small/moderate sized strokes without evidence of haemorrhage on CT scanning at 48 hours can be anticoagulated immediately > 48 hours after onset. Patients with large embolic strokes or uncontrolled hypertension should have anticoagulation deferred for 14 days. N.B. The initial period of anticoagulation with Heparin should be omitted in these patients 12. Patients on antiplatelet therapy who develop an indication for warfarin i) Patients taking an antiplatelet agent for the following indications should stop it when warfarin is commenced for any indication and has reached the therapeutic range: primary prophylaxis for cardiovascular disease peripheral artery disease previous ischaemic stroke secondary prophylaxis with stable ischaemic heart disease (>12 months following myocardial infarction) ii) Patients on a single antiplatelet agent <12 months following an acute coronary syndrome (ACS), who require to start warfarin should continue aspirin until 12 months post ACS, unless they are regarded as having a high risk of bleeding Author: Gail Abrahamson Review Date: September 2017 Page 19 of 73

20 iii) iv) patients on aspirin and clopidogrel, following an ACS or stent placement, who develop an indication for warfarin need careful assessment of bleeding risk and discussion with their cardiologist, with a view to introducing warfarin and minimising the duration of triple therapy When combined warfarin and single antiplatelet agent are indicated, give consideration to use of aspirin given higher bleeding risk of clopidogrel Patients on warfarin who develop indication for antiplatelet agents: Review the need for warfarin If need to continue warfarin, reduce length of time on single/dual antiplatelet therapy Reference: Bcshguidelines.com/currentguidelines/haemostasis and thrombosis Guidelines on oral anticoagulation with warfarin - fourth edition 2011 Author: Gail Abrahamson Review Date: September 2017 Page 20 of 73

21 Warfarin Induction Dosage Chart for Venous Thrombosis (Fennerty nomogram) Reduce dose by approximately 1 / 3 if baseline INR > 1.4; abnormal LFTs; CCF; COPD; Amiodarone A modified loading schedule is recommended for the elderly Day Patients < 75 years INR Warfarin dose mg Patients > 75 years INR Warfarin dose mg 1 < < < >1.8 3 < >4.0 4 < > Miss next dose then 2mg Miss 2 doses then 1mg < >1.6 < >4.0 < > Miss 1 dose then Omit until INR <4.5 Author: Gail Abrahamson Review Date: September 2017 Page 21 of 73

22 Warfarin Induction Dosage Chart for Atrial Fibrillation Patients starting Warfarin for AF do NOT need LMWH (Enoxaparin) and should not be referred to the Early Intervention Team (EIT) / Intermediate Care Team (ICT). They can be anticoagulated more gradually using either the OATES algorithm or the AGENO algorithm if urgent cardioversion is required. AF standard induction protocol (Oates et al 1998) Day INR Dose Interval (days) to next test AF induction for patients requiring early cardioversion. (Ageno 2003) Day INR Dose Interval (days) to next test Outpatients Can be referred to the anticoagulant clinic for initiation of treatment. These patients are prescribed the Warfarin starter pack. N.B. If you initiate treatment, please refer to the anticoagulant clinic making clear which induction programme you are using and giving the date of start of treatment. Inpatients 1. AF Standard induction protocol (OATES et al 1998) Prescribe Warfarin according to induction protocol chosen. On discharge, arrange day 15 testing. (Anticoagulant clinic/eit/ict/other). Refer to anticoagulant clinic (2 3 weeks) These patients do NOT need daily testing and do NOT need LMWH (Enoxaparin) injections. 2. AF induction for patient requiring early cardio version (Agino 2003) Prescribe Warfarin according to protocol. On discharge, refer to EIT/ICT for daily testing Refer to anticoagulant clinic. These patients do NOT need LMWH (Enoxaparin). Author: Gail Abrahamson Review Date: September 2017 Page 22 of 73

23 Warfarin Dosage Maintenance and Monitoring Individual patients vary in their sensitivity to Warfarin and the dose required to achieve a therapeutic INR will vary, most patients requiring a maintenance dose of 3-9mg. The robustness of the maintenance dose also varies from patient to patient and dose modification to maintain a therapeutic INR should be informed by each individual patient s track record. When Warfarin is started, patients should be tested daily until the INR is in the therapeutic range. (Assuming full loading doses are used). If the patient has recently started Warfarin, tests should be at least once or even twice a week. As the patient s dose requirements become clear and the INR settles in the therapeutic range, the interval between testing can be increased eg once a fortnight to once a month. In patients where control is very stable, testing can be done as infrequently as 8-12 weekly. Testing should never be less frequent than once every 12 weeks. In patients with an INR outside the therapeutic range, a dose adjustment will be required. The size of the adjustment will be determined by the deviation of INR from the target, the size of the usual maintenance dose, the presence or otherwise of any destabilising factors (eg concurrent illness, change of medication), presence of known risk factors for haemorrhage/vte and the ease of monitoring the patient. Following a dose adjustment, testing should be brought forward to assess the effect of the change. Frequency of testing should increase again and will be determined by the same factors as influence the size of the dose change. (See above). For those clinics using computer dosage packages, most dose changes and the frequency of testing can be determined by the computer software package according to the preset algorithm. If there is marked deviation of the INR from the therapeutic range, the patient should be seen. Patients with an INR > 6 should be questioned about: 1. The presence of abnormal bleeding/bruising. If present, the need for reversal should be considered (see page 23). b) Possible reasons for poor control: A change of medication Inter-current illness Alcohol interaction/abuse A change in diet (especially fasting) Other change in lifestyle Dose changes to consider include: Continue maintenance but at a lower dose Omit the Warfarin for 1-3 days then revert to the usual maintenance dose Omit the Warfarin for 1-3 days, then restart maintenance at a lower dose Patients with significant haemorrhage, an INR > 10, poor compliance or who are very difficult to control, should be discussed with the Consultant Haematologist. Patients with an INR below the therapeutic range should also be tested more frequently with dose increments until the INR is back in the therapeutic range. NB: UNDER ANTICOAGULATION CAN BE JUST AS DANGEROUS AS OVER ANTICOAGULATION, PARTICULARLY IN THOSE WITH PROSTHETIC HEART VALVES OR A HISTORY OF RECENT THROMBOEMBOLISM. Patients with a very low INR (< 1.4) should be seen and questioned before major dose adjustments are made in order to check compliance and other causative factors. Occasionally, reloading will be required. Author: Gail Abrahamson Review Date: September 2017 Page 23 of 73

24 Management of Surgery (including Dentistry) in Patients on Warfarin Contents General notes A) Patients whose indication for Warfarin means that they require bridging with low molecular weight heparin (LMWH) if the procedure requires an INR of <1.5 and Warfarin must therefore be stopped peri-operatively Bridging process overview Bridging for moderate/high risk Warfarin patients - Pre-operative assessment clinic (POAC)/ Anticoagulant clinic (AC)/ ward process WHHT flowchart for high risk Warfarin patients requiring bridging POAC- letter for patient who requires bridging Instructions for patient on warfarin who requires bridging Letter to Consultant re patient on Warfarin who requires perioperative bridging with low molecular weight heparin Process for patients requiring bridging when egfr <30 ml/min- admission for unfractionated heparin (UFH) B) Patients whose indication for Warfarin means that they DO NOT require bridging if the procedure requires an INR of <1.5 such that Warfarin must be stopped perioperatively Process for patients on warfarin who DO NOT require bridging when INR normalised - Pre-operative assessment clinic (POAC)/ Anticoagulant clinic (AC)/ ward process WHHT flowchart for warfarin patient NOT REQUIRING BRIDGING when INR normalised POAC - letter for NO BRIDGING patient Instructions for patient on warfarin who DOES NOT require bridging when INR normalised Letter to Consultant re patient on Warfarin who DOES NOT require perioperative bridging with low molecular weight heparin when INR normalised C) Emergency Surgery D) Minor surgery or procedure with low bleeding risk E) Dentistry F) GI endoscopy G) Implantation of Permanent Pacemaker (PPM) /intracardiac Device (ICD) H) Cancellation of surgery Author: Gail Abrahamson Review Date: September 2017 Page 24 of 73

25 Management of Surgery (including Dentistry) in Patients on Warfarin General notes In those patients receiving a short (3 months) course of Warfarin, surgery should be deferred until the course has been completed wherever possible. In those patients who have had a recent (within 3 months) thromboembolic event, particularly if extensive, surgery should be delayed unless essential eg. for malignancy. For those patients on Warfarin who require planned surgery, it is necessary to balance the thrombotic risks of stopping anticoagulation with the haemorrhagic risk of surgery in the presence of anticoagulation. The following should be taken into consideration: For minor surgery with little risk of significant haemorrhage, it is safe to proceed with an INR 2. This may not require any adjustment to the Warfarin dose. In some cases (eg simple dentistry) a higher INR may be acceptable. For major and intermediate surgery, with haemorrhagic risk, or if haemorrhage could have serious implications e.g. neuro surgery and ophthalmic surgery, it is desirable to have a period without anticoagulation, operating when the INR is < 1.5. This usually requires cessation of Warfarin for about 5 days. For a short period of time it is probably safe to stop anticoagulation in many patients In a very small number of patients undergoing major surgery and with a high risk of thrombosis, it is necessary to stop Warfarin but to maintain a degree of anticoagulation using a treatment dose of low molecular weight heparin (LMWH), which can then be stopped in the immediate perioperative period. Bridging with unfractionated heparin (UFH) is rarely required and should only be used with close liaison with a Consultant Haematologist to ensure tight control Patients who have been on Warfarin and for whom an INR of <1.5 is required for the procedure should have their INR checked the day before the procedure and receive oral vitamin K if needed. Patients who have received Vitamin K the day before the procedure will need to have the INR rechecked a few hours before surgery. This means they should not be planned early on a morning list which does not leave time for discussion. Warfarin treatment should be restarted post-operatively as soon as the risk of haemorrhage is over and preferably on the evening of the operation or the first postoperative day. Where Warfarin is stopped but bridging is not required patients should have a VTE risk assessment on admission, as would any other patient, and receive appropriate thromboprophylaxis Some patients are difficult to classify with respect to haemorrhagic versus thromboembolic risk. These should be discussed by the surgical team with a Haematologist prior to planning surgery date to ensure management plan is appropriate Author: Gail Abrahamson Review Date: September 2017 Page 25 of 73

26 A) Patients whose indication for Warfarin means that they require bridging with low molecular weight heparin (LMWH) if the procedure requires an INR of <1.5 and Warfarin must therefore be stopped peri-operatively. Patients on long-term Warfarin for the following indications, where there is a high risk of thrombosis when un-anticoagulated, will require bridging if the procedure requires the INR to be normalised: Mitral valve prosthesis (all types) Bileaflet aortic valve with risk factors /caged-ball or tilting disc aortic prosthesis Prosthetic valve +CVA/TIA within 6months VTE within last 3 months Antiphospholipid syndrome AF with CHADS2 score 3 /AF with recent TIA/CVA within last 3 months or rheumatic valve disease C Congestive heart failure 1 H Hypertension BP consistently 1 >140/90 or treated Hypertension on medication A Age 75 years 1 D Diabetes Mellitus 1 S Prior stroke or TIA or thromboembolism 2 Patients on Warfarin for any other indication do not require bridging if the procedure requires an INR of <1.5 such that Warfarin must be stopped perioperatively. See below. NB. These patients must have a VTE risk assessment on admission, as for any other patient, and receive post-procedure thromboprophylaxis if indicated. Bridging process overview: Requires close liaison between preoperative assessment clinic (POAC), Anticoagulant Clinic, ward pharmacist and admitting team 1. Patient seen in POAC and bridging proforma faxed to AC 1. Patient to be reviewed in Anticoagulant Clinic 1-2 weeks before surgery for education, supply and training of administration of LMWH. Check INR. 2. Stop Warfarin 5 days prior to surgery (last dose 6 days before) 3. LMWH (1.5mg/kg to the nearest dose band according to protocol) will commence 3 days prior to surgery and be given at 09:00 daily Last dose 24 hours before procedure. If patient weighs > 125kg, halve last dose 4. INR check to be performed day before surgery and oral Vitamin K given if required 5. Recheck INR on morning of surgery if received Vitamin K 6. OMITT LMWH on the morning of surgery hrs post-operatively, if haemostasis is secure patients can be commenced on prophylactic dose of LMWH 8. Therapeutic LMWH can be recommenced 48 hours after surgery if haemostasis is secure. 9. Restart Warfarin as soon as possible post operatively once risk of haemorrhage has receded and patient has oral intake. Give 1½ x usual maintenance dose for 2 days then check INR and dose accordingly 10. Monitor INR regularly (daily initially) whilst an inpatient and dose according to the maintenance protocol 11. If patient is suitable for discharge before INR check on D+3 of surgery, discharge patient on usual maintenance dose of Warfarin and ensure the patient has an appointment in the Anticoagulant Clinic within a few days of discharge. Author: Gail Abrahamson Review Date: September 2017 Page 26 of 73

27 Bridging for moderate/high risk Warfarin patients - Pre-operative assessment clinic (POAC)/ Anticoagulant clinic (AC)/ ward process POAC 1. POA nurse/ pharmacist to complete CHADS2 score of patient, if relevant 2. If patient has a CHADS2 score > or = 3 or has another indication for bridging, POA nurse/pharmacist to inform the patient of the need for this 3. POA nurse/pharmacist to check wt, GFR and platelets 4. POA nurse/pharmacist to complete bridging proforma ( WHHT high risk Warfarin patients requiring bridging ), sign and fax to patient s local anticoagulant clinic if GFR > or =30ml/min. 5. If GFR < 30 ml/min Admissions Officer to organise patient admission to hospital for intravenous UFH 3 days before surgery date. POAC to inform anticoagulant clinic that patient is to be admitted for UFH (tick box on bridging proforma) 6. POA nurse/pharmacist to give patient letter ( POAC-letter for patient who requires bridging ) reminding them that they will need bridging for surgery. Patient instructed to contact AC once receives date for procedure. 7. POA nurse/pharmacist gives patient a form for DAY -1 INR. 8. POAC files copies of letter and faxed proforma in hospital notes. AC 1. Once informed by the patient of date of surgery AC to send patient appointment for 14-7 days before surgery 2. Patient attends AC 14-7 days before surgery 3. AC nurse checks INR to establish normal warfarin maintenance dose 4. AC nurse assesses suitability for self injection of lmwh or injection by family member and trains if suitable. If not suitable, AC to contact practice nurse to arrange to inject. If patient unable to attend GP practice, AC to contact district nurse. 5. AC nurse gives patient sharps bin and 5 therapeutic doses of LMWH according to the PGD. It is made clear that only 3 of the doses are to be used pre-operatively. The other 2 are to be kept for possible use post-operatively. 6. AC nurse completes and signs bridging plan and gives patent a copy of this and also of instructions to patient ( Instructions for patient on warfarin who requires bridging ) 7. AC nurse faxes copy of bridging protocol to (i) Consultant Surgeon/Physician (ii) Watford POAC pharmacist ( for attention of POAC pharmacist ) and, if applicable (iii) GP surgery,/district nurse. Letter outlining admitting team s responsibility also faxed to consultant ( Letter to Consultant re patient on Warfarin who requires perioperative bridging with low molecular weight heparin ) 8. AC nurse to advise patient that if surgery cancelled they need to restart warfarin at usual maintenance dose and contact AC as soon as possible 9. Patients who are planned for surgery outside the Trust who need bridging will need a GFR and platelet count done prior to being seen in the AC. Blood requests to be sent with an appointment letter if sufficient time. If surgery is imminent then blood tests will need to be requested by nurses from AC Author: Gail Abrahamson Review Date: September 2017 Page 27 of 73

28 Admitting team Day -1 INR 1) The patient will attend the Blood Clinic for the Day -1 INR. If this falls on a non-working day the AC will need to make special arrangements with the admitting team 2) The admitting team will chase the result and contact the patient to arrange Vitamin K if this is required 3) If Vitamin K is administered the admitting team will arrange for a Day 0 pre-op INR Admission The ward pharmacist will liaise with the WGH POAC pharmacist and the junior doctors and oversee the following: 1) Copy of bridging proforma attached to drug chart 2) Post-operative bridging plan followed Discharge Ensure that: (i) (ii) (iii) Pt is re-referred to the AC clinic Pt has arrangement for follow up INR within a few days and is aware of date and place and has clear instructions for LMWH and Warfarin in the meantime. Pt has supply of prophylactic dose of LMWH if required NB: Day cases It is particularly important that the junior doctors ensure that the patient is given a supply of prophylactic dose lmwh to take home. Author: Gail Abrahamson Review Date: September 2017 Page 28 of 73

29 Patient ID label WHHT flowchart for high risk Warfarin patients requiring bridging Indication for anticoagulation Therapeutic range Procedure Consultant Patient Tel: Pre-assessment clinic HGH SACH WGH Weight GFR Platelets CHADS If GFR <30mls/min arrange for admission 3 days prior to surgery date for UFH Pre-op nurse / pharmacist to complete patient details, above, then fax to Anticoagulation clinic: HHGH , SACH , WGH Signed: POA nurse / Pharmacist Date DATE WARFARIN DOSE 18:00) INR test required Low Molecular Weight Heparin (TREATMENT) Time 09:00 Dose: (halve on Day-1 if wt >125kg) Low Molecular Weight Heparin (PROPHYLACTIC) Dose: D-14 to -7 D-5 D-4 D-3 D-2 D-1 Procedure date (D0) No LMWH dose No LMWH dose No need to check No warfarin to be taken * DO INR if >=1.5 Rx Vit K1 2mg po Check INR if had Vit K in last 24hrs Indications for bridging Mitral valve prosthesis (all types) Bileaflet aortic valve with risk factors /cagedball or tilting disc aortic prosthesis/ Prosthetic valve + CVA / TIA within 6mths VTE within last 3 months Antiphospholipid syndrome AF with CHADS2 score 3 /AF with recent TIA/CVA within last 3 months or rheumatic valve disease C Congestive heart failure 1 H Hypertension BP consistently 1 >140/90 or treated Hypertension on medication A Age 75 years 1 D Diabetes Mellitus 1 S2 Prior stroke or TIA or thromboembolism 2 CHADS2 Score D+1 D+2 D+3 D+4 Ward to prescribe * Restart warfarin (1.5x maintenance dose) on the evening of the procedure together with LMWH 6-8 Hours post-op ONLY if haemostasis is secure. Anticoagulant Nurse Date Faxed to consultant Faxed to pharmacist Supplied to patient by anti coag clinic Author: Gail Abrahamson Review Date: September 2017 Page 29 of 73

30 Anticoagulation Department Pathology Department St Albans City Hospital Waverley Road St Albans AL3 5PN Anticoagulation Department Pathology Department Hemel Hempstead General Hospital, Hillfield Road Hemel Hempstead HP2 4AD Anticoagulation Department Pathology Department Watford General Hospital Vicarage Road Watford WD18 0HB Patient ID label POAC- letter for patient who requires bridging Date: Dear patient, Your usual medication includes Warfarin. It is important that prior to your procedure the Warfarin is stopped but that you continue to have anti coagulation treatment by receiving low molecular weight heparin (CLEXANE) as planned in your pre-operative assessment appointment. As soon as you receive notification of your admission date, please telephone the Anticoagulation Department and book an appointment to see the nurse 7-14 days PRIOR to the admission date. The arrangements for the Clexane will be made when you are seen Telephone number for appointments: Monday-Friday 9.30 am-3pm Yours sincerely, The Anticoagulant Clinic team Author: Gail Abrahamson Review Date: September 2017 Page 30 of 73

31 Anticoagulation Department Pathology Department St Albans City Hospital Waverley Road St Albans AL3 5PN Anticoagulation Department Pathology Department Hemel Hempstead General Hospital Hillfield Road HP24AD Anticoagulation Department Pathology Department Watford General Hospital Vicarage Road Watford WD18 0HB Telephone Monday-Friday 9.30am-3pm Instructions for patient on warfarin who requires bridging Patient ID label Indication for Anticoagulation Therapeutic range Procedure Consultant Date of procedure INR Date. Result.. BEFORE THE OPERATION 1) Please take the following WARFARIN dose.. 2) Your last day of WARFARIN before the operation will be: 3) Start the CLEXANE injections on. as follows: Date Time Dose i) am ii) am iii) am 4) Please bring the form which you were given at the Pre-operative Assessment Clinic and come to the Blood Clinic/ other for an INR on the morning of. (date) ie the day before the operation 5) The INR needs to be less than 1.5 before the operation. If it is too high you will be contacted by the doctors to arrange for you to have a small dose of Vitamin K by mouth 6) You have been given 5 doses of CLEXANE at a treatment dose. Three of them are to be used before the procedure, as explained above. Author: Gail Abrahamson Review Date: September 2017 Page 31 of 73

32 Please keep the other two doses but do not use them unless instructed to by a doctor or an Anticoagulation Clinic nurse ON THE MORNING OF THE OPERATION If you had vitamin K the day before the operation, your INR will be rechecked by the doctors to make sure that it is satisfactory. AFTER THE OPERATION i) If the doctors are happy that there is no risk of bleeding WARFARIN and CLEXANE will be started again on the evening of the operation. ii) iii) The dose of WARFARIN will be higher than your usual dose for a couple of days. The dose of CLEXANE will be a smaller one for a couple of days. It may then go on to the treatment dose, which you were given before the operation. BEFORE YOU GO HOME If you are staying in hospital for one or more nights after the operation 1) You may need to continue with CLEXANE for a few days at home. If this is the case the doctors will provide you with instructions about the dose of CLEXANE to use at home and may need to give you a supply of the lower dose for a few days. 2) You will need an INR in the Anticoagulant Clinic within a few days of leaving hospital. The doctors will give you the details of the appointment before you go home. They should also give you instructions about the dose of WARFARIN to take until your INR is checked again. If you are not staying in hospital overnight i) You will need to continue with CLEXANE at home. This will be at a lower dose for a few days. The doctors will provide you with a supply of the lower dose and will give you instructions as to what to use when. 3) You will need an INR in the Anticoagulant Clinic within a few days of leaving hospital. The doctors will give you the details of the appointment before you go home. They should also give you instructions about the dose of WARFARIN to take until your INR is checked again Signed.. Date.. Anticoagulant Nurse Practitioner Author: Gail Abrahamson Review Date: September 2017 Page 32 of 73

33 Anticoagulation Department Pathology Department St Albans City Hospital Waverley Road St Albans AL3 5PN Anticoagulation Department Pathology Department Hemel Hempstead General Hospital Hillfield Road HP24AD Hemel Hempstead HP2 4AD Anticoagulation Department Pathology Department Watford General Hospital Vicarage Road Watford WD18 0HB Patient ID label Telephone Monday-Friday Date: Letter to Consultant re patient on Warfarin who requires perioperative bridging with low molecular weight heparin Dear, This patient is due to be admitted under your care on.. for As there is a significant risk of thrombosis without anticoagulation, s/he will be receiving bridging with Clexane perioperatively. I am attaching a copy of the bridging plan for your team. Please note: 1. The patient will attend. for the Day -1 INR. It is the responsibility of your team to chase the result, contact the patient to arrange Vitamin K if required and arrange for a Day 0 (pre-op) INR if necessary 2. Please ensure that your team liaises with the ward pharmacist to ensure: I. Copy of bridging proforma attached to drug chart II. Post-operative bridging plan followed III. At discharge, the patient: A is re-referred to the Anticoagulant Clinic B has appointment for an INR within a couple of days and is aware of date and place C has clear instructions for LMWH and Warfarin in the meantime. D has a supply of prophylactic dose of LMWH if required. This will be necessary for day cases and short stays. Please contact me if you require any clarification Yours sincerely, Signed:. Anticoagulant Nurse Practitioner Date: Author: Gail Abrahamson Review Date: September 2017 Page 33 of 73

34 Process for patients requiring bridging when egfr <30 ml/min- admission for unfractionated heparin (UFH) If egfr <30mls/min patient will need continuous unfractionated heparin infusion. 1. Organise admission 3 days prior to surgery date 2. Stop Warfarin 5 days prior to surgery ( last dose 6 days before) 3. Measure INR daily after 2 missed doses 4. When INR falls below lower end of patient s therapeutic range initiate agreed heparin regime 5. Monitor heparin using Hep ratio 6. Unfractionated heparin should be stopped 4 hours pre-operatively 7. Recommence Unfractionated heparin 6 hours post-operatively if haemostasis is secure 8. Reload with Warfarin on the first post-operative day if haemostasis is secure. Give 1½ x maintenance dose of Warfarin for 2 days and check INR and dose accordingly 9. Stop heparin when the INR has been > 2 for 24 hours 10. Monitor INR regularly (daily initially) whilst an inpatient and dose according maintenance protocol. 11. If patient is suitable for discharge before INR check on D+3 of surgery, discharge patient on usual maintenance dose of warfarin and ensure the patient has an appointment in the Anticoagulant Clinic within a few days of discharge. B Patients whose indication for Warfarin means that they DO NOT require bridging if the procedure requires an INR of <1.5 such that Warfarin must be stopped peri-operatively Warfarin can be stopped pre-procedure in these patients without the need for perioperative treatment dose LMWH. However these patients MUST have a VTE risk assessment on admission, as for any other patient, and receive post-procedure thromboprophylaxis if indicated. Process for patients on warfarin who DO NOT require bridging when INR normalised - Pre-operative assessment clinic (POAC)/ Anticoagulant clinic (AC)/ ward process POAC 1. POA nurse/ pharmacist to complete CHADS2 score of patient, if relevant 2. If patient has a CHADS2 score < 3and no other indication for bridging, POA nurse/pharmacist to complete the WHHT flowchart for warfarin patient NOT REQUIRING BRIDGING when INR normalised ), sign and fax to patient s local anticoagulant clinic. 3. POA nurse/pharmacist to give patient letter ( POAC- letter for NO BRIDGING patient ). Patient instructed to contact AC once receives date for procedure. 4. POA nurse/pharmacist gives patient a form for DAY -1 INR. 5. POAC files copies of letter and faxed proforma in hospital notes. Author: Gail Abrahamson Review Date: September 2017 Page 34 of 73

35 AC 1. Once informed by the patient of date of surgery AC to send patient appointment for 14-7 days before surgery 2. Patient attends AC 14-7 days before surgery 3. AC nurse checks INR to establish normal warfarin maintenance dose 4. AC nurse informs patient that will need to stop warfarin 5 days in advance of the procedure (ie last dose 6 days before) and have an INR the day before 5. AC nurse completes and signs NO BRIDGING plan and gives patient a copy of this and patient instructions ( Instructions for patient on warfarin who does NOT require bridging when INR normalised ) 6. AC nurse faxes copy of protocol to (i) Consultant Surgeon/Physician (ii) Watford POAC pharmacist ( for attention of POAC pharmacist). Letter outlining admitting team s responsibility also faxed to consultant ( Letter to Consultant re patient on Warfarin who DOES NOT require perioperative bridging with low molecular weight heparin when INR normalised ). 7. AC nurse advises patient that if surgery cancelled they need to restart warfarin at usual maintenance dose and contact AC as soon as possible Admitting team Day -1 INR 1. The patient will attend the Blood Clinic for the Day -1 INR. If this falls on a non-working day the AC will need to make special arrangements with the admitting team 2. The admitting team will chase the result and contact the patient to arrange Vitamin K if this is required 3. If Vitamin K is administered the admitting team will arrange for a Day 0 pre-op INR Admission The admitting team and ward pharmacist will ensure the following: 1. Copy of NO BRIDGING plan attached to drug chart 2. The patient has a VTE risk assessment as for any other patient and thromboprophylaxis with low molecular weight heparin is given if indicated Discharge Ensure that: 1. Pt is re-referred to the AC clinic 2. Pt has arrangement for follow up INR within a few days and is aware of date and place and has clear instructions for Warfarin in the meantime. Author: Gail Abrahamson Review Date: September 2017 Page 35 of 73

36 Patient ID label WHHT flowchart for warfarin patient NOT REQUIRING BRIDGING when INR normalised (Indications for bridging are: ) Mitral valve prosthesis (all types) Indication for anticoagulation Bileaflet aortic valve with risk factors /caged-ball or tilting disc aortic prosthesis Therapeutic range Prosthetic valve + CVA / TIA within 6 mths Procedure VTE within last 3 months Antiphospholipid syndrome Consultant AF with CHADS2 score 3 /AF with recent TIA/CVA within last 3 months or rheumatic valve disease Patient Tel: C Congestive heart failure 1 Pre-assessment clinic HGH SACH WGH H Hypertension BP consistently 1 >140/90 or treated Hypertension on I confirm that this patient DOES NOT have an indication for bridging (see right for indications for bridging) medication Signed: POA nurse / Pharmacist. Date A Age 75 years 1 D Diabetes Mellitus 1 Pre-op nurse/pharmacist to complete and then fax to Anticoagulant clinic: S2 Prior stroke or TIA or 2 thromboembolism HHGH , SACH , WGH CHADS2 Score DATE WARFARIN DOSE 18:00) INR test required D-14 to -7 D-5 D-4 D-3 D-2 D-1 Procedure date (D0) No need to check No warfarin to be taken * * Restart warfarin (1.5x maintenance dose) on the evening of the procedure if haemostasis is secure. Anticoagulant Nurse Date Faxed to consultant Do INR. If >=1.5 Rx Vit K 1 2mg po Check INR if had Vit K in last 24hrs D+1 D+2 D+3 D+4 1) Patient must have VTE risk assessment on admission and receive post-procedure thromboprophylaxis with low molecular weight heparin if indicated 2) Ensure seen in Anticoagulant Clinic within a few days of discharge f: WHHT: C035 Date: September 2014 Version no. 6 thor: Gail Abrahamson Review Date: September 2017 Page 36 of 73

37 Anticoagulation Department Pathology Department St Albans City Hospital Waverley Road St Albans AL3 5PN Anticoagulation Department Pathology Department Hemel Hempstead General Hospital Hillfield Road HP24AD Hemel Hempstead HP2 4AD Anticoagulation Department Pathology Department Watford General Hospital Vicarage Road Watford WD18 0HB Patient ID label POAC- letter for NO BRIDGING patient Date: Dear patient, Your usual medication includes Warfarin. It is important that prior to your procedure the Warfarin is stopped for a few days and then restarted after the operation. In order to plan this you will need to be seen in the Anticoagulant Clinic between one and two weeks before the operation As soon as you receive notification of your admission date, please telephone the Anticoagulation Department and book an appointment to see the nurse 7-14 days PRIOR to the admission date. Telephone number for appointments: Monday-Friday 9.30 am-3pm Yours sincerely, The Anticoagulant Clinic team Author: Gail Abrahamson Review Date: September 2017 Page 37 of 73

38 Anticoagulation Department Pathology Department St Albans City Hospital Waverley Road St Albans AL3 5PN Anticoagulation Department Pathology Department Hemel Hempstead General Hospital Hillfield Road HP24AD Hemel Hempstead HP2 4AD Anticoagulation Department Pathology Department Watford General Hospital Vicarage Road Watford WD18 0HB Instructions for patient on warfarin who DOES NOT require bridging when INR normalised Patient ID label Indication for Anticoagulation Therapeutic range Surgical procedure Consultant Date of operation Pre-assessment clinic HHGH SACH WGH INR Date: Result: BEFORE THE OPERATION 1) Please take the following WARFARIN dose.. 2) Your LAST DAY of WARFARIN before the operation will be:. 3) Please bring the form which you were given at the Pre-operative Assessment Clinic and come to the Blood Clinic/ other for an INR on the morning of. (date) ie the day before the operation 4) The INR needs to be less than 1.5 before the operation. If it is too high you will be contacted by the doctors to arrange for you to have a small dose of Vitamin K by mouth Author: Gail Abrahamson Review Date: September 2017 Page 38 of 73

39 ON THE MORNING OF THE OPERATION If you had vitamin K the day before the operation, your INR will be rechecked by the doctors to make sure that it is satisfactory. AFTER THE OPERATION. WARFARIN will be restarted. The dose will be higher than your usual dose for a couple of days. BEFORE YOU GO HOME You will need an INR in the Anticoagulant Clinic within a few days of leaving hospital. The doctors will give you the details of the appointment before you go home. They should also give you instructions about the dose of WARFARIN to take until your INR is checked again. Signed.. Date.. Anticoagulant Nurse Practitioner Author: Gail Abrahamson Review Date: September 2017 Page 39 of 73

40 Anticoagulation Department Pathology Department Hemel Hempstead General Hospital Hillfield Road HP24AD Anticoagulation Department Pathology Department Hemel Hempstead General Hospital Hillfield Road HP24AD Hemel Hempstead HP2 4AD Anticoagulation Department Pathology Department Watford General Hospital Vicarage Road Watford WD18 0HB Patient ID label Telephone pm Date: Monday-Friday 9.30am- Letter to Consultant re patient on Warfarin who DOES NOT require perioperative bridging with low molecular weight heparin when INR normalised Dear, This patient is due to be admitted under your care on.. for Please note: 1 The patient will attend. for the Day -1 INR. It is the responsibility of your team to chase the result, contact the patient to arrange Vitamin K if required and arrange for a Day 0 (pre-op) INR if necessary 2 Please ensure that your team liaises with the ward pharmacist to ensure: I. Copy of NO BRIDGING proforma attached to drug chart (copy attached) II. The patient has a VTE risk assessment as for any other patient and thromboprophylaxis with low molecular weight heparin is given if indicated III. At discharge, the patient: A B is re-referred to the AC clinic has arrangement for follow up INR within a few days, is aware of date and place and has clear instructions for Warfarin in the meantime. Please contact me if you require any clarification Yours sincerely, Signed: Date:. Anticoagulant Nurse Specialist Author: Gail Abrahamson Review Date: September 2017 Page 40 of 73

41 C) Emergency Surgery STOP WARFARIN Check INR If INR <2.4 - Proceed unless major surgery is anticipated > And /or major surgery is anticipated, follow the protocol for reversal + discuss with the on-call Haematologist D) Minor surgery or procedure with low bleeding risk For some procedures the surgeon may advise that the INR need only be marginally reduced (to e.g.) in which case bridging may not be required. The surgical team must liaise with the Anticoagulant service in good time to make necessary dose adjustments. Some procedures such as joint injections, simple dental treatment and cataract surgery can be carried out without interrupting Warfarin as long as the INR is known not to be >4 E) Dentistry For restorative dentistry in the Community i.e. - Filling a tooth - Root treatments - Anticipated simple extraction - Scaling an INR of <4 is satisfactory. Warfarin should not be discontinued in most patients needing outpatient dental surgery. The INR must be measured within 72 hours of the procedure to ensure that it is <4.0 Tranexamic acid mouthwash should not be used routinely but should be prescribed by the dentist on an individual patient basis where the risks of oozing/bleeding are assessed as high e.g. after scaling for extensive disease. If a single dose of antibiotic is used it is not necessary to check the INR. If a full course is given, the INR should be checked within a few days of starting treatment. Avoid using NSAIDs F) GI endoscopy The Anticoagulant Clinic should be informed if endoscopy is planned for a patient on warfarin, stating the nature of the procedure so that a decision can be made as to whether Warfarin should be discontinued and bridging required. Procedures: at low risk for bleeding safe to perform with INR up to 3.0 Procedures: at high risk for bleeding: discontinue warfarin 5 days before procedure. Consider bridging with LMWH for patients whose indication for Warfarin means that they are at high risk of thrombosis when unanticoagulated. Restart Warfarin on the evening of the procedure unless endoscopist advises otherwise. Author: Gail Abrahamson Review Date: September 2017 Page 41 of 73

42 Condition High risk of thrombosis Mechanical mitral valve AF with valvular heart disease Mechanical valve and prior thromboembolic event Low risk DVT AF without valvular heart disease Biprosthatic valve (xenograft) Mechanical aortic valve Procedure High risk of bleeding Polypectomy Sphincterotomy at ERCP PEG placement Treatment of varices EUS and FNA Low risk Diagnostic upper endoscopy or colonoscopy and mucosal biopsy ERCP +/- stent without sphincterotomy or percut EUS Enteroscopy G) Implantation of Permanent Pacemaker (PPM) /intracardiac Device (ICD) See separate protocol The Cardiologist must inform the Anticoagulant Clinic when a procedure is scheduled and indicate whether or not Warfarin should be stopped. Author: Gail Abrahamson Review Date: September 2017 Page 42 of 73

43 Implantation of PPM/ICD in Patients on Antiplatelet or Anticoagulant Therapy PATIENT for PACEMAKER/ICD Implant Assess in pre-admission clinic Single antiplatelet agent (eg aspirin or clopidogrel) Proceed to implant Dual antiplatelet agents (eg aspirin and clopidogrel) Assess need for second agent and either continue dual therapy or discontinue one agent prior to implant Warfarin NOTES Dual Antiplatelet Therapy The requirement for dual antiplatelet therapy should be assessed. If both are deemed essential (eg PCI with DES within previous year) then both agents will continue throughout the peri-implant period. If both are not deemed essential, one agent may be discontinued temporarily. high risk patients on warfarin Patients on warfarin who are assessed as high risk should NOT discontinue warfarin. The target INR will usually be in the range The INR should be checked 2 days before and dosed accordingly. Unfractionated or Low molecular weight heparin should NOT be given ( bridging results in increased bleeding complications) If INR is too low or too high postpone procedure (If too low do not do procedure and bridge). If the patient is taking an antiplatelet agent in addition to warfarin this should be stopped. low risk patients on warfarin Warfarin should be discontinued 5 days before implant and should recommence at the patient s usual dose on the day following implantation. Patients should have their INR checked at their usual anticoagulation clinic 7-14 days post procedure. All operators should be familiar with the trust policy on reversal of anticoagulation Author: Gail Abrahamson Review Date: September 2017 Page 43 of 73 Low risk e.g. AF without previous CVA or thromboembolic disease Discontinue warfarin 5 days prior to implant High Risk Mechanical valve Recurrent DVT/PE AF with previous CVA or peripheral embolus CONTINUE warfarin Target INR Check not on antiplatelet agent

44 H) Cancellation of Surgery Patients on LMWH as bridging therapy need to be seen urgently in Anticoagulation Clinic to be recommenced on Warfarin if not an inpatient If the Warfarin has been discontinued and LMWH started:- If INR > 2 < 2 - continue Warfarin at usual maintenance dose - give two days of 1½ times the maintenance dose before reverting to the usual maintenance dose Check the INR daily. Discontinue the LMWH when the INR is >2. N.B. If surgery is rescheduled early after cancellation, there may not be time to re-establish anticoagulation with Warfarin. If this seems likely, discuss a management plan with the haematologist. Author: Gail Abrahamson Review Date: September 2017 Page 44 of 73

45 Non- major 1 YES Consider temporary stop/reduction in dose warfarin 4 Rx Vit K 1-3mg po/iv Bleeding with therapeutic INR - do not attribute bleed to warfarin. Investigate source. Dental bleeding: consider tranexamic acid mouthwash Nasal bleeding: consider packing Reversal of Excessive Anticoagulation with Warfarin Bleeding Major 1 Liaise closely with Haematologist Stop warfarin Rx 3 PCC iv. If INR > 3.5 or intracranial bleed give 50iu/kg. If INR < 3.5 give 30 iu/kg. Max dose 3000iu Rx Vit K 5mg iv Check INR after PCC infusion. A second dose can be given if not corrected; D/W Haematologist Head injury: Check INR as soon as possible in all patients, however minor the injury. Urgent CT scan if: reduced Glasgow coma score, loss of consciousness, amnesia, Injury sufficient to cause laceration, bruising or persistent headache. If strong suspicion of intracerebral haemorrhage/haematoma and CT scan and INR not IMMEDIATELY available DO NOT wait reverse INR immediately with PCC PCC dose 50u/kg irrespective of INR. Max dose 3000u Delayed intracerebral bleeding possible even if initial CT scan normal. Correct supra-therapeutic INR into therapeutic range with oral Vit K and maintain at 2.0 for 4 weeks. NO Withhold 1-2 doses. Investigate cause high INR INR >8 1-5mg Vit K 4 po INR > 5 < 8 If other risk factors 2 consider 1-5mg Vit K 4 po Restart warfarin when INR <5. Consider reduced dose 1 Major bleed: bleeding in critical site (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, intramuscular with compartment syndrome) or fall in Hb of 20g/l or more leading to transfusion of two or more units of blood 2 Additional risk factors for bleed: age >70; previous bleeding complications; confusion; tendency to fall; difficult to attend for repeat test; about to embark on vigorous activities 3 Prothrombin complex concentrate (PCC): used for urgent reversal of Warfarin in major haemorrhage. Recheck INR minutes after administration 4 Response to vitamin K: oral 24 hours; iv 6-8 hours. Smaller doses cause less resistance to re-warfarinisation. Additional doses can be given if required degree of reversal not achieved after 24 hours. Note: When reversing warfarin monitor INR more frequently 1-2 weekly in outpatients; daily or every 6 hours in inpatients. Fresh frozen plasma (FFP). Inferior correction. Only use if PCC unavailable. Rapid infusion of large volumes (15ml/kg). Variably effective. 20 minutes to thaw Patients requiring emergency surgery. The use of PCC may be considered for the reversal of warfarin. D/W Haematologist Author: Gail Abrahamson Review Date: September 2017 Page 45 of 73

46 Discharge of Inpatients taking Warfarin At the time of discharge, the INR should be in the therapeutic range if possible. With the pressures for early discharge this cannot always be achieved and even when it is, the INR is unlikely to be stable. This, plus the change in environment, diets and often also in medication on discharge, means that the period of transition is one of high risk, particularly of haemorrhage, and it is essential that timely and robust arrangements are made for ongoing monitoring of the treatment. This is the responsibility of the clinical team looking after the patient. A. For those patients able to attend an anticoagulant clinic (mobile and only need weekly testing): Identify the appropriate clinic ie most convenient for the patient. Complete the Trust Referral to Anticoagulant Clinic form Send referral by fax to the clinic Make appointment in clinic by phone (for DVT/PE this should be within one week of discharge) Arrange transport if required Make sure the patient knows of the appointment, understands the importance of the appointment, knows the practical arrangements and has the relevant patient information. B. For those patients unable to attend clinic because: - either: the INR is not therapeutic and frequent testing is still required (> once a week). These patients remain the responsibility of the clinical team until weekly testing in the clinic can be introduced. Arrangements should be made for these patients to be monitored in the community using the Intermediate Care Team or to return to the hospital and they should have clear instructions as to when and where they should come and who will be checking the INR and dosing them. If the monitoring is delegated to another team, this must be clarified and agreed. Patients should not be kept waiting for monitoring. or: they are housebound or in a Nursing home. These patients need to be managed in the community where services are fragmented. Whatever arrangements are made, they should be robust with clear responsibility identified for both bleeding/testing and for dosing/monitoring.: Discuss with the GP: - some practices have a Specialist Nurse who will visit - some practices will use the District Nursing Services Discuss with senior staff in the nursing home: - some have internal arrangements - some are visited by domiciliary Phlebotomists Discuss with the Anticoagulant Specialist Nurse on site. The Trust Service does not cover the community but occasionally exceptions can be made. If ongoing monitoring is likely to prove difficult/impossible, reconsider the need for anticoagulation. The risk of haemorrhage is greatly increased in the absence of adequate monitoring and for those patients with AF it might be safer to switch them to Aspirin. Author: Gail Abrahamson Review Date: September 2017 Page 46 of 73

47 Documentation for Patients on Warfarin Inpatients The management plan - for patients starting Warfarin should be clearly documented in the medical record and on the prescription chart in the Oral Anticoagulants section.. It should include the following: - Reasons for anticoagulation Risk assessment Target INR Duration of therapy Monitoring arrangements on discharge Any complications, which occur as a result of anticoagulation whilst an inpatient should also be fully documented. Results and Dosage These must be recorded on the prescription chart in the Oral Anticoagulants section. No dose changes should be made without a full review of this record. Anticoagulant Clinic Outpatients The electronic database DAWN All patient records are kept on the database which acts as an electronic patient record and should be kept up to date at all times. It should include: - The patient demographic details including telephone numbers and details of carers and GPs. Management plan including the reason for anticoagulation, target INR, duration, referring team, interacting drugs and relevant medical conditions. The treatment history including all INRs and Warfarin doses appropriately dated, plus the date of next appointment/tests. Free text entries concerning any ongoing issues, which may impact on care e g special communication needs, specific disability, atypical behaviours. Free text entries describing critical incidents (e.g. haemorrhage), changes in circumstances (e.g. pending surgery), data required for audit (e g recent admission), etc. Copies of all communication with the GP and any letters relating to the anticoagulant treatment. Patient held documents On the ward or in the anticoagulant clinic: Warfarin alert card NPSA patient information pack which includes: Warfarin (yellow book) WHHT patient information leaflet as required NPSA information leaflet Oral Anticoagulant Therapy. patients A Guide to our Anticoagulant CLnics After each clinic visit/test: Important information for Author: Gail Abrahamson Review Date: September 2017 Page 47 of 73

48 computer generated letter containing INR result, Warfarin dose and date of next appointment. Patients are encouraged to keep this with them at all times. Alternatively they can copy the results and dosages into their yellow book, which should then be kept with them. After missed appointments (DNA): 1 st and 2 nd DNA Computer generated letter to patient expressing concern with new one-week appointment. 3 rd DNA Computer generated letter to patient as above with new appointment. Computer generated letter to GP requesting details of ongoing treatment and reminder of need for monitoring 4 th DNA Computer generated letter to patient with further one week appointment 5 th DNA Patient episode terminated and responsibility for care reverts to GP. Computer generated letter to GP notifying them of transfer of responsibility. No further appointment sent. Documents for GP Formal notification of first attendance with indication, target, duration, current INR and dose. Formal notification of last attendance/cessation of treatment including ongoing details if appointment is made for thrombophilia testing Notification of persistent DNA after three missed appointments with request for information and intervention. (see above) Notification of five DNAs with transfer of responsibility for care (see above) Annual request for clinical review and need for ongoing treatment. Notification of temporary suspension of patient record on DAWN if patient admitted to hospital or goes abroad for a significant period of time In addition, practices can be kept up to date with INR results and Warfarin dosage in several ways: - a) Ask to see individual patients letter/yellow book b) A monthly report of all patients in a given practice, to include current INR, Warfarin dose and date of next appointment can be made available on request. c) Electronic access can be made to the hospital s patient database through special arrangements with the software company. To be set up by practice, on request. Author: Gail Abrahamson Review Date: September 2017 Page 48 of 73

49 Appendix 7 Author: Gail Abrahamson Review Date: September 2017 Page 49 of 73

50 Appendix 8 Information to be discussed with the Patient when starting Warfarin The amount of detail provided will depend on individual patient needs and levels of understanding. A. BEFORE STARTING TREATMENT Background and concepts: Check the patient s understanding of why they are on Warfarin. Explain if necessary Ensure they know the duration of anticoagulation Explain the mechanism of action of Warfarin ie. it thins the blood. To ensure it is not too thin or too thick, regular testing is required utilising the INR. If appropriate, explain the INR and the concept of the therapeutic range/target. Explain that small fluctuations are expected/acceptable. The need for and importance of regular testing: Everyone needs a different dose. Frequent testing needed to find the right, maintenance dose. Once found, less frequent testing is needed. Average is about 7mg but can vary between mg. It s the INR, which counts, not the dose. There are many interactions with Warfarin which may change the dose required:- Drugs There are many interactions. Main culprits are antibiotics, NSAIDs, antiepileptics, amiodarone. After starting/stopping these, need INR to see if a dose change is required. Others drugs can interact, so avoid unnecessary drugs especially over the counter medication. eg Nurofen, aspirin (use paracetamol) Ensure prescribing/dispensing staff know you are on Warfarin. Notify HCP of any changes in medication Diet Significant changes of diet can affect the INR. e.g Christmas, holidays. Aggressive weight loss/dieting should be avoided An excess of some green vegetables, eg broccoli, can cause loss of control. A sensible, well balanced diet is the best. Alcohol Heavy/binge drinking is dangerous. DON T DO IT A small amount regularly is fine eg 2 units per evening Some people prefer to stop completely and this is often recommended. Potential side effects of poor anticoagulant control Over anticoagulation Minor bleeding is acceptable e.g. gums oozing after cleaning teeth or cuts bleeding after shaving Abnormal/heavy bleeding eg. large inexplicable bruises, haematemesis, rectal bleeding or haematuria should be reported to the Anticoagulant clinic/gp/a&e. The appropriate place will depend on the severity of the bleed, day of the week, time of day, etc. Under anticoagulation Can lead to recurrent/extension of VTE or precipitate CVA/MI. Should take tablets as directed and ensure regular monitoring. Report to doctor/clinic if have missed significant doses or have relevant symptoms. Author: Gail Abrahamson Review Date: September 2017 Page 50 of 73

51 Special situations Pregnancy Contraindicated whilst on Warfarin because crosses the placenta and can affect the foetus. Use proper contraception Report in immediately if pregnancy is suspected (can change to Heparin). Surgery and minor invasive treatment eg. dental treatment, im injections, chiropody If possible defer until anticoagulation is finished If not possible inform appropriate HCP book time/date of procedure agree perioperative management of Warfarin with staff responsible for monitoring control. All procedures can be undertaken, just slightly more inconvenient because they need to be planned more carefully. Hobbies/leisure activities Common queries often centre on, going to the gym, gardening, golf, climbing ladders, etc. Advise moderation in all things and being careful. Even minor injuries will result in more bleeding than if not on Warfarin and should therefore be reported in as soon as possible. High risk activities should be identified. eg skiing, sailing, contact sports, hang gliding, etc. Assess degree of risk. This will depend on level of skill, frequency of undertaking activity, competitive or not, etc Advise of haemorrhagic risk especially following injury. Need to report in for treatment if necessary. Advice also dependent on duration of anticoagulation and importance of activity to quality of life. Patient information Warfarin alert card. To be carried in wallet/handbags for emergencies. Yellow Warfarin information pack. This includes the yellow book which can be used to record results and dosage In house patient information leaflets if appropriate: i) The prevention of Deep Vein Thrombosis (DVT) in Hospital Inpatients ii) DVT Answering your questions (A Patient s Guide) iv) WHHT A Guide to our Anticoagulant Clinics ( July 2013) Explain monitoring process Describe how this works in hospital clinics/community clinic/gp surgery: Clinic times and booking procedures Personnel Paitent checklist asking about recent medication changes/bruising or bleeding/hospital admissions/ procedures Blood tests immediate result, letter in post, telephone call Documentation computerised letter, yellow book. Warfarin tablets colours and dosage. GPs to prescribe Computer systems ensure patients understand that there is human supervision of the computer Author: Gail Abrahamson Review Date: September 2017 Page 51 of 73

52 B. ON DISCONTINUING TREATMENT An appointment should be made to discuss the end of treatment. A telephone discussion can be utilised if there are real problems arranging an appointment. The Warfarin can be stopped immediately with no need to tail it off. The blood will return to normal, it will not thicken up. There is no need for any more monitoring and no more visits to the anticoagulant clinic. Excess tablets should be disposed off safely or returned to the Chemist. In addition, for patients who have had VTE: Explain if thrombophilia testing is required and the process There is an increased risk of recurrence of VTE by virtue of the first episode and the patient should therefore be alert to suspicious symptoms and report in sooner rather than later. There are simple precautions to be taken in high risk situations: Surgery - tell the surgical team of the history of VTE, so thromboprophylaxis can be given. Long-term immobility greater than 4 days. Inform the clinical team of the relevant history. Pregnancy tell Obstetrician of the history of VTE so prophylaxis can be given if appropriate. Oestrogen containing preparations (the oral contraceptive pill, HRT). Avoid if possible and discuss alternatives with GP. Long distance travel greater than 4 hours: - Wear loose clothing - Avoid dehydration (no alcohol) - Break the trip and walk about if possible (when driving) - Exercise feet, ankles, legs (on an aeroplane) walk up and down the aisle if possible - Flight socks. All patients who have had a PE are referred to the Chest Clinic for assessment Author: Gail Abrahamson Review Date: September 2017 Page 52 of 73

53 Appendix 9 Rivaroxaban Switching between the new oral anticoagulants (NOACs) and warfarin Converting from warfarin to rivaroxaban Stop warfarin. Start rivaroxaban when INR 3.0 or less. Converting from rivaroxaban to warfarin There is a potential for inadequate anticoagulation during the transition. Continuous adequate anticoagulation should be ensured during any transition to an alternative anticoagulant. Warfarin should be given concurrently until the INR is 2.0. For the first two days of the conversion period, standard initial dosing of warfarin should be used followed by warfarin dosing as guided by INR testing. NB: While patients are on both rivaroxaban and warfarin the INR should not be tested until just before the next dose of rivaroxaban is due (ie 24 hours after the last dose) as rivaroxaban can contribute to the INR. Once rivaroxaban is discontinued INR testing may be done reliably at least 24 hours after the last dose Dabigatran Converting from warfarin to dabigatran Stop warfarin. Start dabigatran when INR is 2.0 or less. Converting from dabigatran to warfarin Adjust the starting time of the warfarin based on CrCl as follows: CrCl 50 ml/min: start warfarin 3 days before discontinuing dabigatran CrCl 30-< 50 ml/min: start warfarin 2 days before discontinuing dabigatran Because dabigatran can contribute to an elevated INR, INR testing should not be performed until dabigatran has been stopped for at least 2 days Author: Gail Abrahamson Review Date: September 2017 Page 53 of 73

54 Appendix 10 Management of New Oral Anticoagulants (NOACs) in Patients having elective surgery where there is a risk of bleeding DABIGATRAN Pre procedure Assess renal function and procedure risk and follow guidance in table below as to when to stop dabigatran. Renal fxn Half life Stop dabigatran before surgery (egfr ml/min) (hrs) Risk of bleed high/ major surgery Standard 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 Post procedure Major Surgery Prescribe thromboprophylaxis as per VTE risk assessment then convert to full anticoagulation with dabigatran 2-3 days post operation at patient s normal dose Minor surgery Resume dabigatran 24 hours post op at patient s normal dose. If patient has a high VTE risk consider prescribing enoxaparin 40mg on the evening post surgery and then restarting dabigatran the next day RIVAROXABAN Pre-procedure Stop at least 24 hours before the planned surgery/intervention if possible. Renal function should be considered as impairment can significantly increase rivaroxaban plasma levels. Post procedure Major Surgery Prescribe thromboprophylaxis as per VTE risk assessment then convert to full anticoagulation with rivaroxaban 2-3 days post operation at patient s normal dose Minor Surgery Resume 24 hours post surgery at patient s normal dose. If patient has a high VTE risk consider prescribing enoxaparin 40mg on the evening post surgery and then restarting rivaroxaban the next day Emergency surgery in patient on Novel Oral Anticoagulants Contact Consultant Haematologist to discuss the use of activated charcoal, prothrombin complex concentrate and haemofiltration Author: Gail Abrahamson Review Date: September 2017 Page 54 of 73

55 Appendix 11 Local Decisions Open link to see local decisions, patient information and letter templates to GPs. on Anticoagulants: Author: Gail Abrahamson Review Date: September 2017 Page 55 of 73

56 Appendix 12 Procedure to be followed if venous thromboembolism is suspected Outpatients - Guidelines for the Investigation of suspected Pulmonary Emboli Clinical Assessment: History/examination Calculate Clinical Probability using Manchester Modified Wells Score Low or intermediate clinical probability (6 or less) High clinical probability (More than 6) DO D-DIMER NO D-DIMER Result: NEGATIVE Thrombo-embolic disease ruled out. Consider alternative diagnosis Result: POSITIVE Investigate further for cause of high D-Dimer! May not be PE/DVT Arrange appropriate imaging No chronic lung disease and normal CXR V/Q or CTPA Chronic heart/lung disease/ abnormal CXR CTPA Manchester Modified Wells Score Points Clinical signs/symptoms of DVT (swelling/pain) 3 Intra-venous drug use 3 PE is the most likely diagnosis (bloods,ecg,cxr) 3 Heart Rate> Immobility 3 days or surgery within 4 weeks 1.5 Previous DVT or PE 1.5 Haemoptysis 1 Malignancy with treatment or palliative care In last 6 months 1 LOW: <2 MODERATE: 2-6 HIGH: >6 If symptoms of DVT present consider lower limb Doppler/USS Inpatients - The d-dimer algorithm cannot be used for inpatients. If PE suspected clinically please discuss further investigation ( CTPA or VQ scan) with a consultant radiologist. Commence treatment if there is likely to be a delay. If DVT is suspected clinically the patient should be referred for a Doppler USS. Commence treatment if there is likely to be a delay. Author: Gail Abrahamson Review Date: September 2017 Page 56 of 73

57 Appendix 13 Assessment of patient with DVT for Rivaroxaban Signs & symptoms of DVT Wells Score 2 Mandatory bloods U+Es/LFTs/CS/FBC/eGFR Request Doppler USS Assess for provoking factors Major surgery within last 12/52 * Admitted to hospital in the last 90 days Recent long haul flight (>4hrs duration) within last 8 weeks Immobility (bedridden) >72hrs Current leg plaster (including below knee) Recent severe infection** / diarrhoea / dehydration / Inflammatory bowel disease flare up Combined Oral Contraceptive pill (COC) Pregnancy Active Malignancy Confirmed or Suspected Yes No Unprovoked DVT Use Enoxaparin 1.5mg/kg sc daily Positive No USS Doppler result \ Yes any of the above egfr >30mls/min clotting screen / platelet / liver function tests normal Yes Use Rivaroxaban 15mg 12hrly for 3 weeks then 20mg daily for total of 3/12 No Use UFH see iv heparin policy Yes egfr >30mls/min if egfr <30mls/min refer to Anticoagulation Policy Enoxaparin 1mg/kg sc 12hrly Negative Enoxaparin 1.5mg/kg sc daily USS Doppler result Positive Refer to Anticoagulation Clinic Stop Anticoagulation Refer to Anticoagulation Clinic Abdo-pelvic or lower limb surgery + GA time >60mins or other surgery +GA time >90mins * Pneumonia / septicaemia or bedridden with infection for >72hrs ** Author: Gail Abrahamson Review Date: September 2017 Page 57 of 73

58 Appendix 14 Reversal of Dabigatran associated bleeding Consider giving activated charcoal orally, if last dose ingested <2 hours ago Half-life of Dabigatran is hours depending on age (prolonged in severe renal failure) Start Resuscitation measures Monitor BP & urine output Urgent Bloods Tests FBC / Clotting screen U+E / LFT G+S If APPT / TT normal, suggests low levels of Dabigatran, so reversal of Dabigatran may not be required If PCC considered, should be discussed with haematologist (An off-licence use caution should be exercised) Mild bleeding Local haemostatic measures Consider Tranexamic acid* (15mg/kg orally) Delay next dose of Dabigatran Moderate-to-severe bleeding** Local measures incl surgical Fluid replacement Aim for Platelets >75x10 9 /L Tranexamic acid (15mg/kg IV) Contact Haematologist for advice Life-threatening bleeding &/or need for emergency surgery Measures as for moderate-tosevere bleeding Haemodialysis Contact Haematologist for advice Inform Anticoagulant team so record of bleeding associated with dabigatran can be kept to inform future practice Key APPT: activated partial thromboplastin time TT: thrombin time *There is no published data on using tranexamic acid in individuals receiving Dabigatran ** Hb drop 2.0g/L or bleeding in critical site N.B vitamin K / protamine sulphate will not reverse the activity of dabigatran 4hrs of haemodialysis will remove approx 50-60% of Dabigatran from circulation Author: Gail Abrahamson Review Date: September 2017 Page 58 of 73

59 Appendix 15 Reversal of Rivaroxaban associated bleeding Consider giving activated charcoal orally, if last dose ingested <2 hours ago Start Resuscitation measures Monitor BP & urine output Mild bleeding Local haemostatic measures Consider Tranexamic acid* (15mg/kg orally) Delay next dose of Rivaroxaban Moderate-to-severe bleeding** Local measures incl surgical Fluid replacement Aim for Platelets >75x10 9 /L Tranexamic acid (15mg/kg IV) Call Haematologist for advice Consider use of PCC Urgent Bloods Tests FBC / Clotting screen U+E / LFT G+S Life-threatening bleeding &/or need for emergency surgery Measures as for moderate-tosevere bleeding Contact Haematologist for advice Consider PCC Consider rviia N.B vitamin K / protamine sulphate will not reverse the activity of rivaroxaban Half-life of Rivaroxaban 5-13 hours depending on age (prolonged in severe renal failure) If PT normal, suggests low levels of Rivaroxaban, so reversal of Rivaroxaban may not be required If PCC considered, should be discussed with Haematologist (An off-licence use caution should be exercised) Inform Anticoagulant team so record of bleeding associated with Rivaroxaban can be kept to inform future practice Key PCC: prothrombin complex concentrate; PT: prothrombin time *There is no published data on using Tranexamic acid in individuals receiving Rivaroxaban ** Hb drop 2.0g/L or bleeding in critical site Due to the high plasma protein binding Haemodialysis will not remove Rivaroxaban Author: Gail Abrahamson Review Date: September 2017 Page 59 of 73

60 Appendix 16 A Policy on Anticoagulation and Thromboprophylaxis Ratified by: Quality and Safety Group Date of ratification: Date of review: Page 60 of 73