Thromboprophylaxis in Adult General Medical Patients - Guidelines for Management Adapted from the Worcestershire Acute Hospitals NHS Trust Guideline WAHT-MED-010 Version: Provider Quality and Safety Committee Ratified by: Provider Quality and Safety Committee Date ratified: 30 March 2010 Name of originator/author: Sue Lunec, Head of Medicine Management for Provider Services Date issued for publication: June 2010 Review date: June 2012 Expiry date: March 2013 Target audience: WPCT community hospitals clinical staff and contracted clinical staff If you would like this document in other languages or formats (i.e. large print), please contact the Communications Team on 01905 760020 or email communications@worcestershire.nhs.uk WPCT Thromboprophylaxis guideline adopted WHAT guideline WHAT-MED-010 Page 1 of 14
Key individuals involved in developing the document Name Ruth Prince Sue Lunec Designation Clinical Pharmacist for Community Hospitals Head of Medicines Management Circulated to the following individuals for consultation Name Dr Sumit Bhaduri Finbarr Costigan Lisa Levy Maria Wilday Sue LaHiff Ginny Snape Karen Young Linda Ingles Della Lewis Carole Clive Vicky Preece Lesley Way Rosemary Pickford Sue Chauhan Designation Joint Medical Director Joint Medical Director Associate Director of Provider Services Matron/Hospital Manager PWCH Matron Evesham CH Matron Tenbury CH Matron Pershore CH Matron Malvern CH Clinical Governance Team Manager Consultant Nurse Infection Control Associate Director of Nursing and Therapies Patient Safety Manager Clinical Pharmacist for Community Hospitals Clinical Pharmacist for Community Hospitals WPCT Thromboprophylaxis guideline adopted WHAT guideline WHAT-MED-010 Page 2 of 14
Guideline for thromboprophylaxis in adult (18yrs and older) general medical patients Worcestershire PCT has agreed with Worcestershire Acute Hospitals NHS Trust to adopt this guideline for use in the community hospitals with the following exceptions which are indicated in the guideline with **: This guideline should be used by Worcestershire PCT medical and nursing staff and people contracted to work by the PCT including GPs, involved in the care of adult inpatients with an acute medical condition. All patients immobile for three or more days should be assessed for their thrombosis risk. The Department of Health assessment sheet should be completed for each patient and filed in their notes. This does not cover thromboprophylaxis in acute myocardial infarction and stroke. Continuation of thromboprophylaxis page 3. Thromboprophylaxis once commenced should be continued until the patient is fully ambulant. It should be regularly reviewed and only continued after ambulation if the risk of VTE is still high. Please note that enoxaparin is only licensed for use for 14 days. There is positive evidence for use longer than 14 days but the benefit of a reduction in venous thromboembolic events has to be balanced against an increase in the risk of bleeding. The patient should therefore be re-assessed and this should be documented in the patient s notes In addition to the original information in the policy, for those patients in community hospital settings for long periods of time there is potential for their medical condition to deteriorate from stable to acutely unwell. In cases where the initial acute medical condition has been treated and resolved, staff must be aware of the possibility that a patient s medical condition may deteriorate, and in these cases the risk of thrombosis may increase. In such cases it may be appropriate to restart enoxaparin, and monitor the patient s progress closely. The flow chart recommendations on mechanical thromboprophylaxis includes the use of intermittent pneumatic compression devices, these are not available in the community hospitals so graduated compression stockings should be used where appropriate. WPCT Thromboprophylaxis guideline adopted WHAT guideline WHAT-MED-010 Page 3 of 14
Guideline for thromboprophylaxis in adult (18yrs and older) general medical patients 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. Health care professionals must be prepared to justify any deviation from this guidance. Acutely ill medical patients are likely to be immobilised and are at significant risk of developing venous thromboembolic complications during their stay in Hospital. 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 4 or more days. THIS GUIDELINE IS FOR USE BY THE FOLLOWING STAFF GROUPS : All clinical staff treating patients with an acute medical condition**. Dr S Shafeek Lead Clinician(s) Consultant Haematologist, WAHT Approved by both Medical Directorates and by Medicines Safety Committee on 29 th July 2008 WPCT Thromboprophylaxis guideline adopted WHAT guideline WHAT-MED-010 Page 4 of 14
INTRODUCTION 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). Each year over 25,000 people in England alone die from VTE contracted in hospital. This has been the subject of a recent Government Health Select Committee report 2. 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. DVT/PE are to be included in the Healthcare Commissions annual inspection. 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 trials 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. Active cancer or cancer treatment Active heart or respiratory failure Acute medical illness Age over 60 years Antiphospholipid syndrome Behcet s disease Central venous catheter in situ Immobility (for example, paralysis or limb in plaster) Inflammatory bowel disease (for example, Crohn s disease or ulcerative colitis) Myeloproliferative diseases Risk Factors for VTE 10 Nephrotic syndrome Obesity (body mass index 30 kg/m2) Paraproteinaemia Paroxysmal nocturnal haemoglobinuria Personal or family history of VTE Pregnancy or puerperium Recent myocardial infarction or stroke Severe infection Use of oral contraceptives or hormonal replacement therapy Varicose veins with associated phlebitis Inherited thrombophilias WPCT Thromboprophylaxis guideline adopted WHAT guideline WHAT-MED-010 Page 5 of 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 but see note on page 3 **) 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 Contraindications to enoxaparin Creatinine clearance <30ml/min (consider s/c unfractionated heparin (UFH) or a reduced dose of enoxaparin High risk of bleeding A known bleeding disorder/ thrombocytopenia History of heparin induced thrombocytopenia On oral anticoagulants with a therapeutic INR (INR > 2.0) Recent spinal or epidural analgesia. Hemorrhagic stroke or risk of CNS bleed. Ischaemic stroke within one week of onset Aortic aneurysm Acute bacterial endocarditis hypersensitivity to either enoxaparin sodium, heparin or its derivatives including other Low Molecular Weight Heparins Continuation of thromboprophylaxis Thromboprophylaxis once commenced should be continued 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**. WPCT Thromboprophylaxis guideline adopted WHAT guideline WHAT-MED-010 Page 6 of 14
Monitoring of LMWH The standard prophylactic regimen does not require monitoring 11 Graduated compression stockings (GCS) The decision to fit GCS should be made in collaboration with the medical staff. The patient should be measured accurately in order to ascertain the correct size of the stocking. If they are fitted incorrectly, they may be too tight, restricting the circulation, causing a tourniquet effect and thus predisposing to DVT. If they are too loose they will be completely ineffective. It is important to note that even if GCS are fitted correctly they are not 100% effective at preventing DVT. Other preventative measures such as passive leg exercises should be encouraged where appropriate. Contraindications to compression stockings Gross leg oedema Gross pulmonary oedema Ischaemic vascular disease Local leg conditions e.g. gangrene, dermatitis, skin grafts Extreme leg deformity MONITORING TOOL There will be an audit of medical records to measure compliance with these guidelines. STANDARDS % CLINICAL EXCEPTIONS All medical inpatients (aged >18years) who meet the inclusion criteria will receive appropriate thromboprophylaxis 100% None WPCT Thromboprophylaxis guideline adopted WHAT guideline WHAT-MED-010 Page 7 of 14
REFERENCES 1. Cooper 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):7-17 2. House of Commons Health Select Committee.In :The prevention of venous thromboembolism in hospitalised patients, HC99, The Stationary Office Limited, London, England 2005 3. 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 prevention of venous thromboembolism in acutely ill medical patients. (MEDENOX) N Eng J Med 1999; 341:793-800 5. Cohen A T et al. Assessment of venous thromboembolism risk and the benefits of thromboprophylaxis in medical patients Thromb Haemo 2005; 94: 750-9 6. Leizorovicz A et al. Randomised, placebo-controlled trial of dalteparin for the prevention of venous thromboembolism in acutely ill medical patients. Circulation 2004; 110:874-879 7. Cohen A T et al. Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: Randomised placebo controlled trial. BMJ 2006; 332:325-329 8. Scottish and Collegiate Guideline Network (SIGN). Prophylaxis of Venous Thromboembolism. London. SIGN Publication 2002: no.62. Available at www.sign.ac.uk/guidelines. 9. Thromboembolic Risk Factors (THRIFT II) Consensus Group Guidelines. Available at www.clinicalconsensusreports.com 10. NICE Guideline: CG46 Venous thromboembolism 23 April 2007 11. BNF, September 2007 CONTRIBUTION LIST Key individuals involved in developing the document Name Designation Dr S Shafeek Consultant Haematologist Sr D Toby DVT Sister Paul Benham Director of Pharmacy Circulated to the following individuals for comments Name Designation See circulation list Thrombosis Committee Circulated to the following CD s/heads of dept for comments from their directorates / departments Name Directorate / Department Dr D Pitcher Medicine WRH Dr S Vathenen Medicine AH Circulated to the chair of the following committee s / groups for comments Name Dr C Ashton Paul Benham Committee / group Medical Director Medicines Safety Committee WPCT Thromboprophylaxis guideline adopted WHAT guideline WHAT-MED-010 Page 8 of 14
Equality Impact Assessment Stage 1 (Screening Template) Policy or service being assessed Person(s) involved in conducting the assessment Guideline for thromboprophylaxis in adult (18yrs and older) general medical patients Sue Lunec, Head of Medicine Management Ruth Prince, Clinical pharmacist Date the assessment is completed 2 March 2010 Directorate Lead Policy or service lead (Job title and contact details) Lisa levy Sue Lunec, Head of Medicine Management 1. Is this a new or existing policy or service? New Existing 2. What are the aims, objectives and purpose of the policy or service? (include how it fits into strategic objectives) To fulfil the requirement of national guidance To improve the health of patients in the community hospitals 3. Who will benefit from the policy or service and how? Give a brief explanation of how the target audience will benefit? Service Users Staff Partner Organisations Prevention of thrombosis whilst in community hospitals Clear guidance on how to manage the prophylaxis of thrombosis for patients in the community hospitals Joint working with the Worcestershire Acute NHS Trust WPCT Thromboprophylaxis guideline adopted WHAT guideline WHAT-MED-010 Page 9 of 14
4. Does the policy or service contain aspects which cause inequality? E.g. Location of facilities, operational hours etc. NO 5. For each of the six equality strands, answer the questions in the table below with yes or no, with a brief explanation of your decision. Question Race Gender Disability Sexual Orientation Age Religion or Belief a. Do different groups have different needs, no no no no no no experiences, issues and priorities in relation to the proposed policy or service? b. Is there potential for or evidence that the no no no no no no proposed policy or service will not promote equality of opportunity for all and promote good relations between different groups? c. Is there potential for or evidence that the no no no no no no proposed policy or service will affect different population groups differently (including possibly discriminating against certain groups)? d. Is there public concern (including media, academic, voluntary or sector specific interest) in policy or service area about actual, perceived or potential discrimination against a particular population group or groups? no no no no no no 6. If you answer yes to any of the questions, what evidence supports this? Present your evidence stating the question followed by the strand(s) For example: Question: a. Strand: disability and sexual orientation followed by the evidence WPCT Thromboprophylaxis guideline adopted WHAT guideline WHAT-MED-010 Page 10 of 14
7. Provider Services only to answer this question. Are there concerns that the policy or service could have an adverse (negative) impact on terms following human rights principles (FREDA): (See Guidance notes Appendix A) Fairness No Respect No Equality No Dignity No Autonomy No 8. If you answer yes to any of the principles, what evidence supports this? Present your evidence as the principle followed by the evidence. 9. Have any barriers been identified that could inhibit access to the benefits of the policy or service e.g. physical access, information etc? No 10. How will the service or policy be monitored in relation to the six strands and human rights? N/A 11. What level of adverse (negative) impact (high or low) will this policy or service change have on each of the equality groups? Race low WPCT Thromboprophylaxis guideline adopted WHAT guideline WHAT-MED-010 Page 11 of 14
Gender Disability Sexual Orientation Age Religion or Belief Low Low Low Low low 12. What action will you be taking to address these issues? Please complete the action plan. 13. Should the policy or service proceed to a Full Equality Impact Assessment? If so, what are the reasons? NO Develop an action plan Negative Impact identified Action required to address the issues Monitoring Arrangements/How would you measure impact/outcomes in practice Target date for completion Responsibility Progress to date WPCT Thromboprophylaxis guideline adopted WHAT guideline WHAT-MED-010 Page 12 of 14
Once the Equality Impact Assessment has been completed, please fill in the reporting template below and submit with the policy, completed EIA and the action plan. This reporting template is then published as an appendix with the policy/strategy/plan etc. Equality Impact Assessment Report Template Your Equality Impact Assessment Report should demonstrate what you do (or will do) to make sure that your function/policy is accessible to different people and communities, not just that it can, in theory, be used by anyone. o Name of policy or function - Guideline for thromboprophylaxis in adult (18yrs and older) general medical patients o Responsible Manager - Sue Lunec, Head of Medicine Management o Date EIA completed - 2 March 2010 o Description of aims of function/policy - To improve the health of patients in the community hospitals; To fulfil the requirement of national guidance o Brief summary of research and relevant data - See references o Methods and outcomes of consultation o Results of Initial Screening or Full Equality Impact Assessment Initial or Full Equality Impact Assessment? Equality Group Race Gender Disability Age Sexual Orientation Initial Assessment of Impact WPCT Thromboprophylaxis guideline adopted WHAT guideline WHAT-MED-010 Page 13 of 14
Religion or Belief Human Rights 1. Decisions and or recommendations (including supporting rationale) 2. Equality action plan (if required) 3. Monitoring and review arrangements (include date of next full review) Department Directorate Director Report produced by and job title Date report produced Date report published Please send completed Equality Impact Assessment, Report and Action Plan to Kulvinder Hira, email: kulvinder.hira@worcspct.nhs.uk WPCT Thromboprophylaxis guideline adopted WHAT guideline WHAT-MED-010 Page 14 of 14