GUIDELINE FOR THROMBOPROPHYLAXIS IN ADULT (18 YEARS AND OLDER) IN GENERAL MEDICAL PATIENTS AND INPATIENTS UNDERGOING SURGERY

Transcription

1 GUIDELINE FOR THROMBOPROPHYLAXIS IN ADULT (18 YEARS AND OLDER) IN GENERAL MEDICAL PATIENTS AND INPATIENTS UNDERGOING SURGERY SEE SEPARATE GUIDELINES FOR THROMBOPROPHYLAXIS IN OBSTETRICS This guidance does not override the individual responsibility of health professionals to make appropriate decisions according to the circumstances of the individual patient in consultation with the patient and / or carer. Health care professionals must be prepared to justify any deviation from this guideline. This guideline is for use by the following staff groups: All clinical staff treating patients with an acute medical condition. Medical and nursing staff involved in the care of adult inpatients undergoing surgery Venous thromboembolism: Reducing the risk Reducing the risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in patients admitted to hospital. LEAD CLINICIAN(s) Dr S Shafeek Dr Mark Crowther Consultant Haematologist Consultant Haematologist Approved by Medicines Safety Committee on: 1st June 2011 Guideline reviewed and approved by Accountable Director on: 17th April 2014 Approved by Patient Safety and Quality Committee on: 1st April 2011 First Revision date: April 2016 by Chair of Medicine Safety Committee Expiry date: April 2016 A~Inpatient~WR2138~Version 3~Page 1 of 29

2 ASSESSING RISKS OF VTE AND BLEEDING Medical Patients If mobility significantly reduced for > 3 days or If expect to have ongoing reduced mobility relative to normal state plus an VTE risk factor Patient who are at risk of VTE Surgical patients and patients with trauma If total anaesthetic + surgical time >90 minutes or If surgery involves pelvis or lower limb and total anaesthetic + surgical time > 60 minutes or If acute surgical admission with inflammatory or intraabdominal condition or If expected to have significant reduction in mobility or If any VTE risk factor present A~Inpatient~WR2138~Version 3~Page 2 of 29

3 INTRODUCTION Venous thromboembolism (VTE) includes Deep Venous Thrombosis (DVT) and Pulmonary Embolism (PTE). VTE is a relatively common and potentially fatal problem in surgical patients post operatively. All patients undergoing surgery should be assessed at pre-admission clinic or on admission for any predisposing risk factors for VTE so that appropriate prophylactic interventions can be made. Acutely ill medical patients are like to be immobilised and are at risk of developing venous thromboembolic complications during their stay in hospital. Venous thrombosis is a condition in which a blood clot (thrombus) forms in a vein. This can reduce the blood flow through the affected vein, sometimes but not always causing swelling and pain. Venous thrombosis most commonly occurs in the deep veins in the legs, thighs or pelvis. It is usually referred to as deep vein thrombosis (DVT). An embolism is created if all or part of a clot is dislodged from its original site and travels through the venous system. If the clot lodges in the lung, a very serious condition, pulmonary embolism (PE) arises and can easily cause sudden death. Up to 10% of all hospital deaths could be caused by a PE 1. Venous thrombosis can form in any part of the venous system but DVT and PE are the most common and are known as venous thromboembolism (VTE). House of Commons Health Select Committee in: The prevention of venous thromboembolism in hospitalised patients, HC99, The Stationary Office Limited, London, England 2005 Historically VTE has been considered to be a problem only in surgical patients. This is not the case as available data confirm that acutely ill medical patients are at the same risk, if not more, than surgical patients 3,4. This situation requires a deliberate and ongoing strategy to educate and inform healthcare professionals of the need for adequate risk assessment and actions to promote VTE prevention in all adult inpatients 2,5. VTE is a condition that can be reduced, provided that an adequate risk assessment forms part of our day to day routine. DETAILS OF GUIDELINE VTE is largely preventable and in surgical patients prophylaxis with LMWH has been proven to be safe and cost effective. Randomised trials have consistently demonstrated that appropriate use of pharmacological thromboprophylaxis can also reduce the risk of VTE in medical patients. 3 key trials, MEDENOX 4, PREVENT 6 and ARTEMIS 7 have shown risk reduction of DVT of 50-65% with appropriate use of thromboprophylaxis in medical patients. Combined results of these trial show that medical patients are at high risk of VTE when immobilised with acute medical illnesses and this risk can be reduced by the use of pharmacological prophylaxis with LMWHs. Medical thromboprophylaxis is a grade 1 recommendation in the ACCP 3 guidelines and is recommended in both SIGN 8 and THRIFT II 9 consensus group guidelines. These guidelines all recommend the use of pharmacological thromboprophylaxis in acutely ill medical patients who exhibit risk factors for VTE in whom there is no contraindication and inpatients undergoing surgery. The aim of this guideline is to prevent the development of venous thromboembolism (VTE) in general medical patients admitted into hospital with a serious acute medical condition that is likely to result in the patient being immobilised for 3 days or more, and inpatients undergoing surgery. A~Inpatient~WR2138~Version 3~Page 3 of 29

4 CARE PATHWAY Patient admitted to hospital Assess VTE risk Assess bleeding risk Balance risks of VTE and bleeding Offer VTE prophylaxis if appropriate. Do not offer pharmacological VTE prophylaxis if patient has any risk factor for bleeding and risk of bleeding outweighs risk of VTE Reassess risks of VTE and bleeding within 24 hours of admission and whenever clinical situation changes For all patients Do not allow patients to become dehydrated unless clinically indicated. Encourage patients to mobilise as soon as possible. Do not regard aspirin or other antiplatelet agents as adequate prophylaxis for VTE. Consider offering temporary inferior vena caval filters to patients who are at very high risk of VTE (such as patients with previous VTE event or active malignancy) if mechanical and pharmacological VTE prophylaxis contraindicated). For patients having elective surgery Oral contraceptives and HRT Advise women to consider stopping oestrogen-containing contraceptives or HRT 4 weeks before surgery Pre-existing antiplatelet therapy Assess risks and benefits of stopping pre-existing antiplatelet therapy 1 week before surgery. Consider involving the multidisciplinary team in the assessment. Anaesthesia Consider regional anaesthesia, in addition to other methods of VTE prophylaxis, as it carries a lower risk of VTE than general anaesthesia. Take into account patient preferences, suitability for regional anaesthesia and any other planned method of VTE prophylaxis. If regional anaesthesia is used, plan the timing of pharmacological prophylaxis to minimise risk of epidural haematoma. If antiplatelet or anticoagulant agents are being used or their use is planned, refer to the summary of product characteristics for guidance about safety and timing of these agents in relation to regional anaesthesia. Do not routinely offer pharmacological or mechanical VTE prophylaxis to patients having surgery with local anaesthesia by local infiltration with no limitation of mobility. A~Inpatient~WR2138~Version 3~Page 4 of 29

5 OVERVIEW OF CARE WAHT-HAE-015 WHO WHEN WHAT Patients having Before admission Advise women to consider stopping oestrogencontaining oral contraception or HRT 4 weeks before Elective surgery surgery. Assess the risks and benefits of stopping antiplatelet therapy 1 week before surgery. Refer to Trust Guideline Nil by Mouth and Peri-operative Medicines Use Guidelines for the Management of Antiplatelet therapy. Plan anaesthesia (see page 4) All patients All patients All patients Patients discharged with VTE prophylaxis At admission During ward-based care Before discharge Before discharge Assess risk of VTE. Assess risk of bleeding. Offer patients verbal and written information on VTE. Offer VTE prophylaxis if appropriate. Reassess risks of VTE and bleeding. Review VTE prophylaxis Monitor use of mechanical VTE prophylaxis (see page 8). Keep patients hydrated and encourage them to mobilise as soon as possible. Offer information on signs and symptoms of DVT and PE. Offer information on the importance of seeking medical help and who to contact if DVT, PE or other adverse event suspected. Offer information on correct use and duration of VTE prophylaxis to be used at home and who to contact for help. Ensure patients are able to use the VTE prophylaxis at home, or have someone available to help them. Offer information on signs and symptoms of adverse events related to VTE prophylaxis and who to contact for help. Thromboprophylaxis Patient Information Booklet available from Service Point UK Reference No: WR2044 Ensure Oasis/Bluespier is updated to highlight a risk assessment has been completed. A~Inpatient~WR2138~Version 3~Page 5 of 29

6 KEY PRIORITIES FOR IMPLEMENTATION continued Patient information and planning for discharge Before starting VTE prophylaxis, patients and/or their families or carers should be given verbal and written information on: - the risks and possible consequences of VTE - the importance of VTE prophylaxis and its possible side-effects - the correct use of VTE prophylaxis (for example, anti-embolism stockings, foot impulse or intermittent pneumatic compression devices) - how patients can reduce the risk of VTE (such as keeping well hydrated and, if possible, exercising and becoming more mobile. As part of the discharge plan, offer patients and/or the families or carers verbal and written information on: - the signs and symptoms of deep vein thrombosis and pulmonary embolism - the correct and recommended duration of use of VTE prophylaxis at home (if discharge with prophylaxis) - the important of using VTE prophylaxis correctly and continuing treatment for the recommended duration (if discharged with prophylaxis) - the signs and symptoms of adverse events related to VTE prophylaxis (if discharge with prophylaxis) - the importance of seeking help and who to contact if they have any problems using the prophylaxis (if discharge with prophylaxis) - the importance of seeking medical help and who to contact if deep vein thrombosis, pulmonary embolism or another adverse sent is suspected. PATIENT CENTRED CARE Treatment and care should take into account patients individual needs and preferences. Good communication is essential, supported by evidence-based information, to allow patients to reach informed decisions about their care. Follow Department of Health advice on seeking consent from the Department of Health if needed. If the patient agrees, families and carers should have the opportunity to be involved in decisions about treatment and care. A~Inpatient~WR2138~Version 3~Page 6 of 29

7 ANTI-EMBOLISM STOCKINGS Do not offer anti-embolism stockings to patients with: - suspected or proven peripheral arterial disease - peripheral arterial bypass grafting - peripheral neuropathy or other causes of sensory impairment - local condition in which stockings may cause damage, such as fragile tissue paper skin, dermatitis, gangrene or recent skin graft - known allergy to material of manufacture - cardiac failure - severe leg oedema or pulmonary oedema from congestive heart failure - unusual leg size or shape - major limb deformity preventing correct fit Use caution and clinical judgement when applying anti-embolism stockings over venous ulcers or wounds. Measure legs and use correct stocking size. Staff who fit stockings should be trained in their use and should show patients how to use them. If oedema or post-operative swelling develops, ensure legs are re-measured and stockings refitted. If arterial disease suspected, seek expert opinion before fitting stockings. Use stockings that provide graduated compression and produce a calf pressure of 14-15mmHg. Encourage patients to wear the stockings day and night from admission until they no longer have significantly reduced mobility. Remove stockings daily for hygiene purposes and to inspect skin condition. If patient has significant reduction in mobility, poor skin integrity or sensory loss, inspect skin two or three times per day, particularly over heels and bony prominences. Discontinue use of stockings if there is marking, blistering or discolouration of skin, particularly over heels and bony prominences, or if patient has pain or discomfort. If suitable, offer intermittent pneumatic compression or foot impulse devices as alternative. Show patients how to use anti-embolism stockings correctly and ensure they understand that this will reduce the risk of developing VTE. Monitor use of anti-embolism stockings and offer assistance if they are not being worn correctly. FOOT IMPULSE AND INTERMITTENT PNEUMATIC COMPRESSION DEVICES Do not offer these devices to patients with a known allergy to the material of manufacture. Encourage patients on the ward who have these devices to use them for as much of the time as is possible and practical, both when in bed and when sitting in a chair. A~Inpatient~WR2138~Version 3~Page 7 of 29

8 VTE PROPHYLAXIS FOR PATIENT ALREADY HAVING ANTIPLATELET OR ANTICOAGULANT THERAPY TO TREAT OTHER CONDITIONS Consider offering additional mechanical or pharmacological VTE prophylaxis if patient is at risk of VTE. Take into account risk of bleeding and of co-morbidities such as arterial thrombosis. - If the risk of VTE outweighs the risk of bleeding, consider offering pharmacological VTE prophylaxis according to the reason for admission. - If the risk of bleeding outweighs the risk of VTE, offer mechanical VTE prophylaxis. Do not offer additional pharmacological or mechanical VTE prophylaxis to patients who are taking vitamin K antagonists and who are within their therapeutic range, providing anticoagulant therapy is continued. Do not offer additional pharmacological or mechanical VTE prophylaxis to patients who are having full anticoagulant therapy (for example, fondaparinux sodium, LMWH or UFH) A~Inpatient~WR2138~Version 3~Page 8 of 29

9 Balance risks of VTE and bleeding before offering VTE prophylaxis MEDICAL PATIENTS General Medical Patients Does risk of VTE outweigh risk of bleeding? YES NO Is pharmacological VTE prophylaxis contraindicated YES NO Has patient been admitted for stroke? Offer pharmacological VTE prophylaxis with any one of: - fondaparinux - LMWH 5 YES NO - UFH 6 See separate Risk Assessment on page 11 Continue until patient no longer at increased risk of VTE Consider offering mechanical VTE prophylaxis with any one of - anti-embolism stockings (thigh or knee length) - foot impulse devices Reassess risks of bleeding and VTE - Intermittent pneumatic within 24 hours of admission and compression devices (thigh whenever clinical situation changes or knee length) 5 At the time of publication (Jan 2010) some types of LMWH do not have UK marketing authorisation for VTE prophylaxis in medical patients. Prescribers should consult the summary of product characteristics for the individual LMWH. Informed consent for off-labels use should be obtained and documented. 6 For patients with renal failure. A~Inpatient~WR2138~Version 3~Page 9 of 29

10 RISK ASSESSMENT FOR VENOUS THROMBOEMBOLISM (VTE) & BLEEDING Affix Patient Label here or record NAME: NHS NO: HOSP NO: D.O.B: D D M M Y Y Y Y MALE FEMALE Admission Date Time PATIENTS WHO ARE AT RISK OF VTE: TO BE COMPLETED BY CLINICIANS FOR ALL PATIENTS ON ADMISSION Admission Type: MEDICAL Active cancer or cancer treatment Age > 60 years Dehydration Known thrombophilias Personal history or first degree relative with history of VTE One or more significant medical co-morbidities (for example: heart disease, metabolic, endocrine or respiratory pathologies; acute infectious disease inflammatory conditions) Obesity (BMI > 30 kg/m 2 ) Use of HRT Use of oestrogen-containing contraceptive therapy Varicose vein with phlebitis Pregnancy or <6weeks post partum (see separate pregnancy risk assessment chart) Significantly reduced mobility for 3 days or more Hip or knee replacement Hip fracture Total anaesthetic + surgical time > 90 minutes Surgical involving pelvis or lower limb with a total anaesthetic + surgical time > 60 minutes Acute surgical admission with inflammatory or intra-abdominal condition Critical care admission Surgery with significant reduction in mobility Any additional VTE risk factors considered significant by clinicians PATIENTS WHO ARE AT RISK OF BLEEDING All patients who have any of the following: Active bleeding Acquired bleeding disorders (such as acute liver failure) Concurrent use of anticoagulants known to increase the risk (such as warfarin with INR>2) Fondaparinux - Dabigatran - Rivaroxaban - Apaxibam Acute stroke Thrombocytopenia (platelets <75 x 10 9 /1) Uncontrolled systolic hypertension (> 230/120 mmhg) Untreated inherited bleeding disorders (such as haemophilia or von Willebrand s disease) Neurosurgery, spinal surgery or eye surgery Other procedure with high bleeding risk Lumbar puncture/epidural/spinal anaesthesia expected within the next 12 hours Lumbar puncture/epidural/spinal anaesthesia expected within the next 4 hours Any additional bleeding risk factors considered significant by clinicians e.g. head injury SURGICAL Is patient likely to stay for more than 24hrs: YES If YES, please complete the full form. If NO, sign and date form. ALL PATIENTS RECEIVING GENERAL ANAESTHETIC REQUIRE FULL ASSESSMENT AND FORM COMPLETION Please Tick if relevant Please Tick if relevant NO Post 24hr check Post 24hr check Assessment on Admission: Signature: Print Name: Date: Assessment Post 24hr: Signature: Print Name: Date: COMPLETION OF THE REVERSE OF THIS FORM IS COMPULSORY A~Inpatient~WR2138~Version 3~Page 10 of 29

11 Please attach patient sticker here or record Name: NHS NO: Hosp NO: D.O.B: D D M M Y Y Y Y Male Female Patient admitted to hospital Assess VTE Risk Assess bleeding risk Is one or more risk factor present? If YES, patient is at risk of VTE; continue to follow flow chart If NO, and patient has no change in mobility risk assessment complete; tick option 5 below. Complete Patients who are at risk of VTE checklist overleaf Does patient have one or more risk factors for bleeding? If YES, patient is at risk of / from bleeding Complete Patients who are at risk of bleeding Checklist overleaf Balance risks and complete risk assessment by ticking one recommendations box below See contra-indications to GCS table below 1. Risk VTE > bleeding & GCSs not contraindicated GCSs and Enoxaparin 2. Risk VTE > bleeding & GCSs contraindicated No GCSs, Enoxaparin only 3. Risk bleeding > VTE & GCSs not contraindicated GCSs only, no Enoxaparin 4. Risk bleeding > VTE, GCSs contraindicated No GCSs, no Enoxaparin 5. No risk factors and no change in mobility No VTE prophylaxis needed 6. Concurrent use of anticoagulants known to increase the risk (such as warfarin with INR>2) Fondaparinux - Dabigatran - Rivaroxaban 7. Renal Impairment (GFR <30ml/min) Adjust Enoxaparin appropriately CONTRAINDICATIONS TO GRADUATED COMPRESSION STOCKINGS Acute Stroke Suspected or proven peripheral arterial disease Peripheral arterial bypass grafting Peripheral neuropathy or other causes of sensory impairment Leg ulceration / wounds or other conditions where stockings may cause / worsen damage Cardiac failure with marked leg oedema Severe leg oedema of any cause Major limb deformity or unusual leg size / shape preventing correct fit Date of Assessment Verbal information given to patient YES / NO Practitioner Name Designation: Written information given to patient YES / NO Signature: While in hospital the balance of risk may change (e.g. bleeding risk after stroke, trauma, surgery etc can diminish rapidly) so reassess after 24 hours and regularly thereafter. Platelet count after day 5 of Enoxaparin or earlier if indicated. FILE IN INPATIENT SECTION OF MEDICAL NOTES A~Inpatient~WR2138~Version 3~Page 11 of 29

12 GYNAECOLOGY RISK ASSESSMENT FOR VENOUS THROMBOEMBOLISM (VTE) & BLEEDING Affix Patient Label here or record NAME: NHS NO: HOSP NO: D.O.B: D D M M Y Y Y Y MALE FEMALE Admission Date Time TO BE COMPLETED BY CLINICIANS FOR ALL PATIENTS ON ADMISSION Admission Type: ELECTIVE EMERGENCY Is patient likely to stay for more than 24hrs: YES If YES, please complete the full form. If NO, sign and date form. ALL PATIENTS RECEIVING GENERAL ANAESTHETIC REQUIRE FULL ASSESSMENT AND FORM COMPLETION NO GYNAECOLOGY PATIENTS WHO ARE AT RISK OF VTE: Active cancer or cancer treatment Age > 60 years Dehydration Known thrombophilias Personal history or first degree relative with history of VTE One or more significant medical co-morbidities (for example: heart disease, metabolic, endocrine or respiratory pathologies; acute infectious disease inflammatory conditions) Obesity (BMI > 30 kg/m 2 ) Use of systemic HRT Use of oestrogen-containing contraceptive therapy Varicose vein with phlebitis Pregnancy or <6 weeks post partum (see separate pregnancy risk assessment chart) Significantly reduced mobility for 3 days or more Hip or knee fracture or replacement in the last 6 weeks Pelvic surgery with a total anaesthetic + surgical time > 60 minutes Acute surgical admission with inflammatory or intra-abdominal condition Critical care admission Surgery with significant reduction in mobility Any additional VTE risk factors considered significant by clinicians PATIENTS WHO ARE AT RISK OF BLEEDING All patients who have any of the following: Active bleeding Acquired bleeding disorders (such as acute liver failure) Concurrent use of anticoagulants known to increase the risk (such as warfarin with INR>2) Fondaparinux - Dabigatran - Rivaroxaban - Apaxibam Acute stroke Thrombocytopenia (platelets <75 x 10 9 /1) Uncontrolled systolic hypertension (> 230/120 mmhg) Untreated inherited bleeding disorders (such as haemophilia or von Willebrand s disease) Other procedure with high bleeding risk Lumbar puncture/epidural/spinal anaesthesia expected within the next 12 hours Any additional bleeding risk factors considered significant by clinicians e.g. head injury Please Tick if relevant Please Tick if relevant Post 24hr check Post 24hr check Assessment on Admission: Signature: Print Name: Date: Assessment Post 24hr: Signature: Print Name: Date: COMPLETION OF THE REVERSE OF THIS FORM IS COMPULSORY A~Inpatient~WR2138~Version 3~Page 12 of 29

13 Please attach patient sticker here or record Name: NHS NO: Hosp NO: D.O.B: D D M M Y Y Y Y Male Female Procedures that do not reduce mobility do not increase the risk of VTE and so do not require additional prophylaxis. For example: Hysteroscopy / TCRE / Ablation, colposcopy, cystoscopy, TVT / Mid urethral tape, vulval biopsy, diagnostic laparoscopy lasting <60mins If complications or other risk factors consider treating as per Major Surgery Major surgery includes procedures likely to reduce mobility or to have a duration in excess of 60 minutes A new VTE assessment must be completed if transferring the patient s care to medicine or surgery *Risk factors are listed overleaf Early mobilisation Consider Compression stockings for 7 days if poor post op mobility or 2 risk factors* 5 days Enoxaparin if 3 or more risk factors* and reduced mobility or previous VTE. Compression stockings for all patients for 28 days unless contraindicated Enoxaparin until fully mobile or for 5 days whichever is sooner. No value in single dose If malignancy, however early stage, or if 3 or more risk factors*, previous VTE or reduced mobility Compression stockings for 28 days Enoxaparin for 28 days CONTRAINDICATIONS TO GRADUATED COMPRESSION STOCKINGS Acute Stroke Suspected or proven peripheral arterial disease Peripheral arterial bypass grafting Peripheral neuropathy or other causes of sensory impairment Leg ulceration / wounds or other conditions where stockings may cause / worsen damage Cardiac failure with marked leg oedema Severe leg oedema of any cause Major limb deformity or unusual leg size / shape preventing correct fit Date of Assessment Verbal information given to patient YES / NO Practitioner Name Designation: Written information given to patient YES / NO Signature: While in hospital the balance of risk may change (e.g. bleeding risk after stroke, trauma, surgery etc can diminish rapidly) so reassess after 24 hours and regularly thereafter. Platelet count after day 5 of Enoxaparin or earlier if indicated. FILE IN INPATIENT SECTION OF MEDICAL NOTES A~Inpatient~WR2138~Version 3~Page 13 of 29

14 The following flowchart should be used when deciding whether a medical patient should be prescribed enoxaparin for thromboprophylaxis. Is the patient an adult who is acutely ill (likely to be immobilised for 3 or more days) with one or more VTE risk factors? YES Is low molecular weight heparin contraindicated? NO YES Give enoxaparin (Clexane) 40mg* once daily s/c (*review dose at extremes of body weight) Consider mechanical thromboprophylaxis with graduated compression stockings (GCS) or intermittent pneumatic compression (IPC) 3 Renal Impairment (GFR <30ml/min) Adjust Enoxaparin appropriately Give 20mg Enoxaparin (Clexane) s/c CONTINUATION OF THROMBOPROPHYLAXIS Thromboprophylaxis once commenced should be continue until the patient is fully ambulant. It should be regularly reviewed and only continued after ambulation if the risk of VTE is still high. For some patients it may be appropriate to continue enoxaparin for a short period post discharge. This must be agreed with the consultant in charge. Enoxaparin is licensed for a maximum of 14 days prophylaxis in medical patients. MONITORING OF LMWH The standard prophylactic regimen does not require monitoring A~Inpatient~WR2138~Version 3~Page 14 of 29

15 PATIENTS ADMITTED FOR STROKE Balance risks of VTE and bleeding before offering VTE prophylaxis Do not offer anti-embolism stockings for VTE prophylaxis Does patient have major restriction of mobility, previous history of VTE, dehydration or co-morbidity (such as malignant disease)? Yes No Reassess within 24 hours of admission and whenever clinical situation changes Haemorrhagic stroke excluded? Yes Risk of bleeding (haemorrhagic transformation of stroke or bleeding into another side) low? No No Consider offering foot impulse or intermittent pneumatic compression device until patient can have pharmacological VTE prophylaxis Yes Consider offering prophylactic - dose LMWH 7 (or UFH 8 ) When acute event over and patient s condition stable Stop LMWH7 (or UFH8) 7 At the time of publication (Jan 2010) some types of LMWH do not have UK marketing authorisation for VTE prophylaxis in medical patients. Prescribers should consult the summary of product characteristics for the individual LMWH. Informed consent for off-labels use should be obtained and documented. A~Inpatient~WR2138~Version 3~Page 15 of 29

16 Balance risks of VTE and bleeding before offering VTE prophylaxis Patients with Cancer Patients with central venous catheters Is patient having oncological treatment and ambulant? Is patient ambulant? Yes No Yes No Do not routinely offer pharmacological or or mechanical VTE prophylaxis VTE risk increased? Do not routinely offer pharmacological or or mechanical VTE prophylaxis VTE risk increased? Yes No Yes No Offer fondaparinux, LMWH 9 (or UFH 10 ) Consider offering LMWH 9 (or UFH 10 ) Continue until patient no longer at increased risk of VTE Reassess within 24 hours of admission and whenever clinical situation changes 9 At the time of publication (Jan 2010) some types of LMWH do not have UK marketing authorisation for VTE prophylaxis in medical patients. Prescribers should consult the summary of product characteristics for the individual LMWH. Informed consent for off-labels use should be obtained and documented. 10 For patients with renal failure. A~Inpatient~WR2138~Version 3~Page 16 of 29

17 Balance risks of VTE and bleeding before offering VTE prophylaxis Patients in palliative care If patient has potentially reversible acute pathology If patient in terminal care or end-of-life care pathway Do not routinely offer pharmacological or mechanical VTE prophylaxis Consider offering fondaparinux, LMWH 11 (or UFH 12 ) Review decisions about VTE prophylaxis daily, taking into account potential risks and benefits and views of the patient, family and/or carers and multidisciplinary team 11 At the time of publication (Jan 2010) some types of LMWH do not have UK marketing authorisation for VTE prophylaxis in medical patients. Prescribers should consult the summary of product characteristics for the individual LMWH. Informed consent for off-labels use should be obtained and documented. 12 For patients with renal failure. A~Inpatient~WR2138~Version 3~Page 17 of 29

18 Balance risks of VTE and bleeding before offering VTE prophylaxis NON-ORTHOPAEDIC SURGERY Gastrointestinal surgery If VTE risk increased Bariatric surgery Gynaecological, thoracic and urological surgery If VTE risk increased Offer mechanical VTE prophylaxis 14 at admission. Continue until mobility no longer significantly reduced. Offer mechanical VTE prophylaxis 14 at admission. Continue until mobility no longer significantly reduced. If risk of major bleeding low If risk of major bleeding low Add fondaparinux, LMWH (or UFH 15 ) Continue until mobility no longer significantly reduced (generally 5-7 days) Add LMWH (or UFH 15 ) Continue until mobility no longer significantly reduced (generally 5-7 days) Extend pharmacological prophylaxis to 28 days post-operatively for patients who have had major cancer surgery in the abdomen or pelvis Extend pharmacological prophylaxis to 28 days post-operatively for patients who have had major cancer surgery in the abdomen or pelvis 14 Choose any one of: anti-embolism stockings (thigh or knee length) foot impulse device intermittent pneumatic compression devices 15 For patients with renal failure. A~Inpatient~WR2138~Version 3~Page 18 of 29

19 Balance risks of VTE and bleeding before offering VTE prophylaxis Neurological (cranial or spinal) surgery Vascular surgery 18 Other surgery Surgery 18 including Day Case If VTE risk increased If VTE risk increased If VTE risk increased If VTE risk increased Offer mechanical VTE prophylaxis 16 at admission. Continue until mobility no longer significantly reduced. If risk of major bleeding low Offer mechanical VTE prophylaxis at admission 16 unless patients have peripheral vascular disease If peripheral arterial disease present, seek expert opinion before fitting anti-embolism stockings. Offer mechanical VTE prophylaxis at admission 16 Continue until mobility no longer significantly reduced. Offer mechanical VTE prophylaxis at admission 16 Continue until mobility no longer significantly reduced. Is patient having neurological surgery and has ruptured cranial or spinal vascular malformations (for example, brain aneurysms) or acute traumatic or non-traumatic haemorrhage? Yes DO not offer LMWH (or UFH 15 ) until lesion is secured or condition stabilised Continue until mobility no longer significantly reduced. If risk of major bleeding low Add LMWH (or UFH 17 ) Continue until mobility no longer significantly reduced (generally 5-7 days) If risk of major bleeding low Add fondaparinux or LMWH (or UFH 17 ) Continue until mobility no longer significantly reduced, including after discharge (generally 5-7 days) 16 Choose any one of: anti-embolism stockings (thigh or knee length) foot impulse device intermittent pneumatic compression devices 17 For patients with renal failure. 18 Many vascular surgical patients are already having antiplatelet or anticoagulant therapy. A~Inpatient~WR2138~Version 3~Page 19 of 29

20 Balance risks of VTE and bleeding before offering VTE prophylaxis Hip Fracture Other othopaedic surgery At Admission Offer mechanical VTE prophylaxis with any one of: anti-embolism stockings (thigh or knee length), used with caution foot impulse devices intermittent pneumatic compression devices (thigh or knee length) Continue until patient s mobility no longer significantly reduced. Provided there are no contraindications, offer LMWH (or UFH23) if using. At admission Assess patient s risk of VTE If VTE risk increased Upper Limb surgery Do not routinely offer VTE prophylaxis 24 hours before surgery Stop fondaparinux if it has been used (only recommended after surgery) 12 hours before surgery Stop LMWH (or UFH 23 ) if using. 6 hours after surgical closure Offer fondaparinux if using, provided haemostatis has been established and there is no risk of bleeding. Continue for 28 days hours after surgery Restart LMWH (or UFH 23 ) if using. Continue for 28 days 24 After assessing risks and discussing with patient: Consider offering mechanical VTE prophylaxis with any one of: - anti-embolism stockings (thigh or knee length), used with caution - foot impulse devices - intermittent pneumatic compression devices (thigh or knee length) Consider offering LMWH (or UFH 23 ) 6-12 hours after surgery. Continue mechanical VTE prophylaxis and LMWH (or UFH23) until patient s mobility no longer significantly reduced. 23 For patients with renal failure. 24 According to the summary of product characteristics for the individual agent being used. A~Inpatient~WR2138~Version 3~Page 20 of 29

21 Thromboprophylaxis (VTE) Risk Assessment - Orthopaedic At admission Documented VTE Risk Assessment completed No Contra-indications to thromboprophylaxis NO PATIENT RELATED RISK FACTORS One or more Patient related Risk Factors Elective Hip Replacement Surgery Graduated compression stockings AND Enoxaparin 40mg once daily by subcutaneous injection continued for 28 days after surgery Enoxaparin 40mg by subcutaneous injection once daily to start on evening before surgery or 6-12hours after surgery. To continue for 28 days after surgery Elective Knee Replacement Surgery Graduated compression stockings for 6 weeks. Enoxaparin 40mg once daily by subcutaneous injection continued for 14 days after surgery Enoxaparin 40mg once daily by subcutaneous injection 6-12 hours after surgery continued for 14 days after surgery Hip Fracture Surgery Graduated compression stockings for 6 weeks. Enoxaparin 40mg once daily by subcutaneous injection to start at admission - to stop 12 hours before planning surgery and restart again 6-12 hours after surgery. To continue for 28 days after surgery Enoxaparin 40mg once daily by subcutaneous injection to start at admission - to stop 12 hours before planning surgery and restart again 6-12 hours after surgery. To continue for 28 days after surgery If patient is needle phobic Rivaroxaban 10mg daily orally. 35 days for elective hip replacement surgery 14 days for elective knee replalcement surgery While in hospital the balance of risk may change (e.g. bleeding risk after stroke, trauma, surgery etc can diminish rapidly) so reassess after 24 hours and regularly thereafter. Check platelet count after day 5 of Enoxaparin or earlier if indicated. ORTHOPAEDIC PATIENTS - OTHER CATEGORIES No standard thromboprophylaxis for other orthopaedic patients. Patients need to be assessed individually regarding their risk profile. A decision regarding the possible benefit/risk ratio of thromboprophylaxis needs to be taken by the responsible consultant. A~Inpatient~WR2138~Version 3~Page 21 of 29

22 Balance risks of VTE and bleeding before offering VTE prophylaxis Patient admitted with major trauma Patient admitted with spinal injury. Liaise with Spinal Specialist as appropriate Offer mechanical VTE prophylaxis at admission or as soon as clinically possible, with any one of: anti-embolism stockings (thigh or knee length), used with caution foot impulse devices intermittent pneumatic compression devices (thigh or knee length) Continue until patient s mobility no longer significantly reduced. Assess patient s risks of VTE and bleeding If risk of VTE outweighs risk of bleeding If bleeding risk low Offer LMWH (or UFH 25 ) Continue until mobility no longer significantly reduced Regularly reassess risks of VTE and bleeding 25 For patients with renal failure. A~Inpatient~WR2138~Version 3~Page 22 of 29

23 Balance risks of VTE and bleeding before offering VTE prophylaxis Lower limb plaster casts Patient having lower limb plaster cast Assess patient s risks of VTE If VTE risk increased Consider offering LMWH (or UFH 26 ) after evaluating risks and benefits and based on clinical discussion with patient. Continue until plaster cast removed 26 For patients with renal failure. A~Inpatient~WR2138~Version 3~Page 23 of 29

24 BLEEDING RISK Where bleeding risk is assessed to outweigh the thrombotic risk smaller doses e.g. 20mg enoxaparin may be used at discretion of the consultant surgeon. MANAGEMENT OF PATIENTS WITH RENAL IMPAIRMENT A dosage adjustment is required for patients with severe renal impairment (creatinine clearance < 30ml/min) according to the following tables, since enoxaparin sodium is renally excreted and hence may accummulate in severe renal impairment. Moderate and mild renal impairment: Although no dosage adjustments are recommended in patients with moderate renal impairment or mild renal impairment (creatinine clearance >30ml/min) careful clinical monitoring is advised. Severe Renal Impairment: Low molecular weight heparins are renally excreted and hence accumulate in severe renal impairment (creatinine clearance <30ml/min). Due to the increased risk of bleeding, dosage adjustments are recommended in patients with severe renal impairment. DOSAGE ADJUSTMENT FOR PROPHYLACTIC DOSAGE RANGE Severe Renal Impairment 20mg Enoxaparin SC once daily or unfractionated Heparin should be considered Monitoring Risk assessment and clinical monitoring are the best predictors of the risk of potential bleeding. Routine anti- Xa activity monitoring is usually not required. However, anti-xa activity monitoring might be considered in those patients treated with LMWH who also have either an increased risk of bleeding (such as those with renal impairment, elderly and extremes of weight) or are actively bleeding. A~Inpatient~WR2138~Version 3~Page 24 of 29

25 OUTPATIENTS UNDER GENERAL ANAESTHETIC UNDERGOING DAY CASE SURGERY The following flowchart should be used when decided whether a surgical patient shold be prescribed enoxaparin for thromboprophylaxis VTE RISK ASSESSMENT COMPLETED As a cohort the following surgical day case procedures are not associated with impairment of patient s mobility and can be defined as not requiring thromboprophylaxis. They will be counted within the cohort approach detailed above. 1. Patients undergoing surgical procedure with local anaesthesia by local infiltration with no limitation of mobility (1) 2. Ophthalmological procedures with local anaesthetic/regional/sedation and not full general anaesthetic. 3. Endoscopy procedures - cystoscopy, upper and lower GI endoscopy. 4. Other similar minor procedures lasting less than 90 minutes which require regional anaesthetic or sedation and not full general anaesthetic to be signed off by the medical director. All patients admitted for intra-abdominal or lower limb day case surgery lasting for greater than 90 minutes require VTE assessment and pharmacological prophylaxis if clinically appropriate. All surgical patients undergoing procedure that will impair their mobility post procedure require VTE assessment and treatment where indicated. In some patients therapi will need to be continued for 5 days. This is general guidance and, as ever, clinical judgement in individual patients overrides. One or more risks factors LMWH Contra-indicated No risk factors identified if risk of bleeding greater identified than risk of VTE 40mg Enoxaparin Any risk identified LOW RISK OD Post Op Surgery >30 mintes - no risk Consider mechanical More than 1 Risk thromboprophylaxis with Early mobilisation OR graduated compression Previous DVT/PE stockings OR Thrombophilias OR Any additional VTE Risk factors considered significant by clinicians. Consider extended thromboprophylaxis 40mg daily for five days This guidance does not override the individual responsibility of health professionals to make appropriate decision according to the circumstances of the individual patient in consultation with the patient and/or carer. Healthcare professionals must be prepared A~Inpatient~WR2138~Version 3~Page 25 of 29

26 PLANNING FOR DISCHARGE Offer patients and/or their families or carers verbal and written information on: - signs and symptoms of DVT and PE - importance of seeking medical help and who is contact if DVT, PE or other adverse event suspected. If discharge with VTE prophylaxis, also offer patients and/or their families or carers information on: - correct use and duration of VTE prophylaxis at home - importance of using VTE at home correctly and for recommended duration - signs and symptoms of adverse events related to VTE prophylaxis - who to contact if they have problems using VTE prophylaxis at home If discharged with anti-embolism stockings, ensure that the patient: - understands the benefits of wearing them - understands the need for daily hygiene removal - is able to remove and replace the stockings or has someone who can do this - knows what to look for, such as skin marking, blistering or discolouration, particularly over heels and bony prominences - knows who to contact if there is problem. If discharged with pharmacological or mechanical VTE prophylaxis ensure that: - the patient is able to use it or has someone who can do this - the patient s GP is notified A~Inpatient~WR2138~Version 3~Page 26 of 29

27 TRAINING WAHT-HAE-015 Training will be provided in accordance with the Trusts training needs analysis. MONITORING TOOL This should include realistic goals, time frames and measurable outcomes. How will monitoring be carried out? - Audit of medical records, point prevalence audit. Who will monitor compliance with the guideline? - Medical Directorates Clinical Governance Groups. Audit of medical records and point prevalence audits will be carried out by the Thromboprophylaxis CNS and FYIs at least annually. Results of the audit will be reviewed at the thromboprophylaxis group and/or Haematology Directorate and will be disseminated to the medical directorates clinical governance/directorate meetings. Each directorate will be expected to produce their own action plan and monitor progress against it. STANDARDS % CLINICAL EXCEPTIONS All medical/surgical inpatients (aged 100 None >18 years) who meet the inclusion criteria will receive appropriate thromboprophylaxis All appropriate patients have a risk 100 None assessment completed and is filed in their notes. REFERENCES: 1. Copper JW & Groce J III. DVT/PE prophylaxis in medically ill patients: a new avenue of clinical management in the long term care setting. Consult pharm 2001; 16 (suppl D): House of Commons Health Select Committee in: The prevention of venous thromboembolism in hospitalised patients, HC99, The Stationary Office Limited, London, England Geerts WH et al. Prevention of venous thromboembolism. The Seventh ACCP conference on antithrombotic and thrombolytic therapy. Chest 2004; 126: 338S-400S. 4. Samama MM et al.a comparison of Enoxaparin with placebo for the prevent of venous thromboembolism in acutely ill medical patients. (MEDENOX) N Eng J Med 1999; 341: Cohen A T et al. Assessment of venous thromboembolism risk and the benefits of thrombrophylaxis in medical patients Thromb Haemo 2005; 94: Leizorovicz A et al. Randomised, placebo-controlled trial of dalteparin for the prevention of venous thromboembolism in acutely ill medical patients. Circulation 2004; 110: Cohen A T et al. Efficacy and safety of fondaparainux for the prevention of venous thromboembolism in older acute medical patients: Randomised placebo controlled trial. BMJ 2006; 332: Scottish and Collegiate Guideline Network (SIGN). Prophylaxis of Venous Thromboembolism. London. SIGN Publication 2002: No. 62, available at 9. Thromboembolic Risk Factors (THRIFT II) Consensus Group Guidelines. Available at NICE Guideline: CG46 Venous thromboembolism 23 April BNF, September Effectiveness of thigh-length graduated compression stockings to reduce the risk of deep vein thrombosis after stroke (clots trial 1) a multicentre, randomised controlled trial. The Lancet, Volume 373, Issue 9679, pages , 6th June, 2009, doi / (09) Nice Clinical Guidelines January Summary of product characteristics. Sanofi Aventis. +and+clexame+multidose+vial (accessed ) 15. NICE CG92 19th May 2011 Venous Thromboembolism. A~Inpatient~WR2138~Version 3~Page 27 of 29

28 SUMMARY OF MEASURES INTRODUCED AS PART OF THE NATIONAL VTE PREVENTION PROGRAMME FOR THE NHS NHS Operating Framework 2010/11 VTE prevention is included in the NHS Operating Framework for which canbe found on the DH website at: digitalasset/dh_ pdf. The NHS Operating Framework states explicitly that professional leadership in the area of VTE prevention will be provided by the Academy of Medical Royal Colleges. This represents a unique partnership between the Royal Colleges and NHS Management in improving patient safety. Revision of NICE clinical guideline The National Institute for Health and Clinical Excellence (NICE) have published a new comprehensive clinical guideline on VTE risk management for all hospitalised patients. This is now Clinical Guideline 92: Venous thromboembolism - reducing the risk. It can be found on the NICE website at Revision of National VTE Risk Assessment Tool DH has developed and agreed this tool with NICE and it is available at: The revised risk assessment tool is fully aligned to new Clinical Guideline 92 and describes the clinical risk assessment criteria that clinical teams should use in order to ensure that risk assessment is consistent with the clinical guideline. Mandatory data collection Ministers have given approval for a new national mandatory data collection from 1 June 2010 which will require providers to report each month on the proportion of patients risk-assessed for VTE on admission to hospital using the national tool. Detailed guidance on this data collection is available in draft form on the UNIFY system currently. NHS Standard Contract From 1st April 2010, the NHS Standard Contract for acute services requires providers to: report to their lead commissioner on local audits of the percentage of patients risk-assessed for VTE who receive the appropriate prophylaxis, both the risk assessment and the prophylaxis being based on national guidance. (Where appropriate prophylaxis is used but is not based on national guidance, the reasons for this clinical decision will need to be fully documented). undertake and report to their lead commissioner on root cause analysis of all confirmed cases of hospital acquired pulmonary embolism (PE) and deep vein thrombosis (DVT) (including those arising from a current stay or new events arising where there is a history of admission to hospital within the last three months, but not including patients admitted to hospital with a confirmed VTE with no history of an admission to hospital within the last three months. National goal on VTE within acute provided CQUIN schemes for The national VTE goal will link CQUIN payment to the benchmark of at least 90% of adult patients being riskassessed for VTE on admission to hospital. The new data collection via UNIFY will be the basis for assessing provider compliance with the CQUIN goal in 2010/11, and again evidence of use of the clinical risk assessment criteria described in the national tool will be sought. This is indicated within published guidance on the CQUIN payment framework: Regulation We will be asking the Care Quality Commission (CQC) to include VTE risk assessment within the CQC national indicators and assessment requirements for 2010/11. Further information Resources exist to support the NHS in implementing VTE prevention. More information can be found at: A~Inpatient~WR2138~Version 3~Page 28 of 29

29 CONTRIBUTION LIST WAHT-HAE-015 KEY INDIVIDUALS INVOLVED IN DEVELOPING THIS DOCUMENT Name Sister Margaret Wilson Dr S Shafeek Designation Thromboprophylaxis CNS Consultant Haematologist CIRCULATED TO THE FOLLOWING INDIVIDUALS FOR COMMENTS Name Thromboprophylaxis Committee consisting of: Nick Hubbard Charles Ashton Dr S Shafeek Margaret Wilson Mr Knebel Miss Duckett Mr Docker Keith Hinton Miss Thirumalaikumar Designation CD for Pharmacy Medical Director Consultant Haematologist Thromboprophylaxis CNS T&O Consultant Gynaecology Consultant T&O Consultant Pharmacy Lead for Surgery Gynaecology Consultant CIRCULATED TO THE FOLLOWING CD S / HEADS OF DEPARTMENT FOR COMMENTS FROM THEIR DIRECTORATES / DEPARTMENTS Name Directorate/Department CIRCULATED TO THE CHAIR OF THE FOLLOWING COMMITTEE S / GROUPS FOR COMMENTS Name Nick Hubbard Dr S Shafeek Mrs Helen Blanchard Committee / Group Medicines Safety Committee Consultant Haematologist Patient Safety & Quality Committee A~Inpatient~WR2138~Version 3~Page 29 of 29