Guideline Venous Thromboembolism (VTE) Prophylaxis Guideline 1. Purpose This guideline outlines the requirement for risk assessment, prescribing, administration and monitoring of venous thromboembolism (VTE) prophylaxis for adult women admitted to the Women s Hospital. Venous thromboembolism (VTE) is a major cause of morbidity and mortality and is one of the most preventable causes of death 1,2. Hospitalised women are 100 times more likely to develop VTE than those in the community. Pregnancy is a risk factor for VTE3,4 and is higher post-partum, following caesarean section, preterm or stillbirth or women with a very high body mass index (BMI) 5. Major gynaecological surgery has a significant risk of both asymptomatic and symptomatic VTE. There is a substantial level of evidence supporting the use of pharmacological VTE prophylaxis, together with adequate hydration, early mobilisation and graduated compression stockings (GCS) in hospitalised women with risk factors. Low molecular weight heparin for VTE prophylaxis in pregnant women is preferred 1,5,7. Aspirin is not first-line therapy for prophylaxis 1. 2. Definitions Pharmacological: Medicines used for thromboprophylaxis. This may include the use of low molecular weight heparin, unfractionated heparin, warfarin and/or aspirin Mechanical prophylaxis: Stockings, pneumatic compression, early mobilisation and surveillance BMI: body mass index HRT: hormonal replacement therapy IPC: intermittent pneumatic calf compression GCS: graduated compression stocking LMWH: low molecular weight heparin PAC: pre-admission clinic ONC-PAC: Oncology pre-admission clinic. 3. Responsibilities The decision to administer VTE prophylaxis is a team responsibility i.e. both surgeons and anaesthetists have an equal responsibility to consider VTE prophylaxis. Medical staff responsibilities: VTE risk assessment and documentation (should include consideration of age, renal function, comorbidities, other medicines and appropriate indications/contraindications). VTE prophylaxis prescribed when indicated: o Caesarean section VTE prophylaxis to be prescribed by anaesthetists o Gynaecology/Oncology VTE prophylaxis to be prescribed by surgical registrar o Antenatal and vaginal birth - Obstetric medical team has overall responsibility for ensuring the VTE risk assessment is performed and documented and VTE prophylaxis is prescribed where indicated. Ongoing risk assessment and safety monitoring for VTE prophylaxis. Nursing/midwifery staff responsibilities: Correct administration of prescribed VTE prophylaxis and application of mechanical prophylaxis Notify the prescriber when the condition of the patient changes. 4. Guideline There are 4 steps to ensuring all women at risk receive appropriate VTE prophylaxis: (also see Appendix 1) Step 1: Assess the patient for VTE risk. Step 2: Assess for contraindications to VTE prophylaxis. Uncontrolled document when printed Updated/Formatted: (19/02/2015) Approved by QSC on 16/02/2015 Page 1 of 6
Guideline Venous Thromboembolism (VTE) Prophylaxis Guideline Reasons for contraindication include active bleeding or a high risk of bleeding. These women require compression stockings and/or sequential compression devices. Assess patient for CONTRAINDICATIONS to mechanical prophylaxis, e.g. Local trauma to the lower limb. Step 3: Prescribe VTE prophylaxis. Prophylaxis should generally be started within 24 hours of admission or after surgery and should be continued until discharge or post-discharge where appropriate. Step 4: Review the patient. At discharge, review the patient for the need of extended VTE prophylaxis. 5. Evaluation, monitoring and reporting of compliance to this guideline Compliance to this guideline will be monitored, evaluated and reported through incidents, and/ or audit. 6. References 1. Wickham N, Gallus AS, Walters BNJ, Wilson A, the NVTEPGAC. Prevention of venous thromboembolism in patients admitted to Australian hospitals: summary of National Health and Medical Research Council clinical practice guideline. Internal medicine journal. 2012;42(6):698-708. 2. Bates SM, Jaeschke R, Stevens SM, Goodacre S, Wells PS, Stevenson MD, et al. Diagnosis of DVT: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e351S-418S. 3. McColl MD, Ramsay JE, Tait RC, Walker ID, McCall F, Conkie JA, et al. Risk factors for pregnancy associated venous thromboembolism. Thromb Haemost. 1997 Oct;78(4):1183-8. 4. Simpson EL, Lawrenson RA, Nightingale AL, Farmer RD. Venous thromboembolism in pregnancy and the puerperium: incidence and additional risk factors from a London perinatal database. BJOG. 2001 Jan;108(1):56-60. 5. Sultan AA, Tata LJ, West J, Fiaschi L, Fleming KM, Nelson-Piercy C, et al. Risk factors for first venous thromboembolism around pregnancy: a population-based cohort study from the United Kingdom. Blood. 2013 May 9;121(19):3953-61. 6. Gould MK, Garcia DA, Wren SM, Karanicolas PJ, Arcelus JI, Heit JA, et al. Prevention of VTE in nonorthopedic surgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e227S-77S. 7. Bates SM, Greer IA, Middeldorp S, Veenstra DL, Prabulos AM, Vandvik PO. VTE, thrombophilia, antithrombotic therapy, and pregnancy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e691S-736S. 8. Koller M, Schoch U, Buchmann P, Largiader F, von Felten A, Frick PG. Low molecular weight heparin (KABI 2165) as thromboprophylaxis in elective visceral surgery. A randomized, double-blind study versus unfractionated heparin. Thrombosis and haemostasis. 1986 Dec 15;56(3):243-6. 9. Comparison of a low molecular weight heparin and unfractionated heparin for the prevention of deep vein thrombosis in patients undergoing abdominal surgery. The European Fraxiparin Study (EFS) Group. Br J Surg. 1988 Nov;75(11):1058-63. 10. Kakkar VV, Cohen AT, Edmonson RA, Phillips MJ, Cooper DJ, Das SK, et al. Low molecular weight versus standard heparin for prevention of venous thromboembolism after major abdominal surgery. The Thromboprophylaxis Collaborative Group. Lancet. 1993 Jan 30;341(8840):259-65. 11. Boneu B. An international multicentre study: Clivarin in the prevention of venous thromboembolism in patients undergoing general surgery. Report of the International Clivarin Assessment Group. Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis. 1993 Dec;4 Suppl 1:S21-2. 12. Horlocker TT, Wedel DJ, Rowlingson JC, Enneking FK, Kopp SL, Benzon HT, et al. Regional anesthesia in the patient receiving antithrombotic or thrombolytic therapy: American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition). Regional anesthesia and pain medicine. 2010 Uncontrolled document when printed Updated/Formatted: (19/02/2015) Approved by QSC on 16/02/2015 Page 2 of 6
Guideline Venous Thromboembolism (VTE) Prophylaxis Guideline Jan-Feb;35(1):64-101. 13. Macklon NS, Greer IA. Venous thromboembolic disease in obstetrics and gynaecology: the Scottish experience. Scott Med J. 1996 Jun;41(3):83-6. 7. Legislation/Regulations related to this guideline Not applicable. 8. Appendices Appendix 1 Risk Stratification and Recommended VTE Prophylaxis. PGP Disclaimer Statement The Royal Women's Hospital Clinical Guidelines present statements of 'Best Practice' based on thorough evaluation of evidence and are intended for health professionals only. For practitioners outside the Women s this material is made available in good faith as a resource for use by health professionals to draw on in developing their own protocols, guided by published medical evidence. In doing so, practitioners should themselves be familiar with the literature and make their own interpretations of it. Whilst appreciable care has been taken in the preparation of clinical guidelines which appear on this web page, the Royal Women's Hospital provides these as a service only and does not warrant the accuracy of these guidelines. Any representation implied or expressed concerning the efficacy, appropriateness or suitability of any treatment or product is expressly negated In view of the possibility of human error and / or advances in medical knowledge, the Royal Women's Hospital cannot and does not warrant that the information contained in the guidelines is in every respect accurate or complete. Accordingly, the Royal Women's Hospital will not be held responsible or liable for any errors or omissions that may be found in any of the information at this site. You are encouraged to consult other sources in order to confirm the information contained in any of the guidelines and, in the event that medical treatment is required, to take professional, expert advice from a legally qualified and appropriately experienced medical practitioner. NOTE: Care should be taken when printing any clinical guideline from this site. Updates to these guidelines will take place as necessary. It is therefore advised that regular visits to this site will be needed to access the most current version of these guidelines. Uncontrolled document when printed Updated/Formatted: (19/02/2015) Approved by QSC on 16/02/2015 Page 3 of 6
Appendix 1 Risk Stratification and Recommended VTE Prophylaxis Step 1: Assess the patient for VTE prophylaxis Every woman on admission to the Women s hospital must have a formal assessment for VTE prophylaxis which will require review if the clinical status changes. The VTE Risk Assessment section on the Medicines Chart must be completed. VTE prophylaxis, when indicated, must be prescribed by the medical staff responsible for the care of the patient. The prescription for VTE prophylaxis must include compression stockings when indicated. The risk of VTE and the appropriateness of prophylaxis must be reviewed during the patient s hospital stay to ensure changes to the patient s clinical condition (e.g. sepsis, bleeding, surgical intervention) are not compromised by prophylaxis treatment. Risk factors for VTE that require VTE prophylaxis consideration: 1. Pregnancy Assisted birth (Rotational forceps) Parity of 3 or more Caesarean birth Labour 24 hours Pregnancy related medical illness (such as pre-eclampsia) Stillbirth 2. Current cancer 3. Blood dyscrasia Antiphospholipid syndrome/antibody Personal history of VTE Family History or Thrombophilia 4. Lower body pathophysiology 5. Patient factors (3 or more) Major pelvic or abdominal surgery Gross varicose veins Paralysis of lower limbs Age > 35 years BMI 30 Current infection Continuous travel > 3 hours (air travel) or prolonged immobility Excessive blood loss Dehydration Pre-existing major medical illness (e.g. heart/lung disease, inflammatory bowel disease) Central venous catheter in situ Oral contraceptive or HRT Smoker Step 2: Assess the patient for contraindications Contraindications to pharmacological VTE prophylaxis: On current therapeutic anticoagulation Active bleeding Individual risks of bleeding as assessed by treating doctor or surgeon Severe coagulation disorders or haemorrhaging of major organ Uncontrolled document when printed Updated/Formatted: (19/02/2015) Approved by QSC on 16/02/2015 Page 4 of 6
Appendix 1 Risk Stratification and Recommended VTE Prophylaxis Adverse reaction to low molecular weight heparin e.g. rash, HITTs Hepatic failure or renal failure. Contraindications to mechanical prophylaxis: Severe peripheral vascular disease Severe peripheral neuropathy Severe lower limb oedema Extreme leg deformity Inflammatory conditions of the lower leg e.g.: ulcer Morbid obesity (where correct fitting of GCS cannot be achieved). For antiplatelet and anticoagulant cessation prior to surgery, refer to the guideline Perioperative Management of Antiplatelet and Anticoagulation in Elective Surgery. Step 3: Prescribe VTE prophylaxis The decision about timing of the dose is guided by the responsible surgical unit and/or anaesthetist if the patient had regional anaesthetic. The low molecular weight heparin of choice for VTE prophylaxis at the Women s is dalteparin, however other low molecular weight heparins are also available. Dose of dalteparin for VTE prophylaxis In general, the dose of VTE prophylaxis depends on the patient s body weight, age and renal function. In women with normal renal function and < 75 years of age, the recommended dose is according to the table below: Weight (kg) Dose of dalteparin (in patients with normal renal function < 40kg 2500 units 40 to 100kg 2500 to 5000 units > 100 kg 7500 units Dosing frequency (subcutaneous injection) In women with renal impairment or 75 years, the dose of VTE prophylaxis may need to be reduced. Consult the haematology unit for further advice. Administration of dalteparin for VTE prophylaxis The dosing frequency is usually every 24 hours. The timing of the dose is guided by the type of procedure as well as the post-operative bleeding risk. daily Unless specified by the surgical treating unit, the following is recommended 13. Epidural: Epidural catheters should be removed at least 12 hours after a dose of VTE prophylaxis Following epidural catheter removal, subsequent doses of VTE prophylaxis should be administered no earlier than 6 hours after removal and subsequent doses should be administered daily. Regional anaesthesia: Regional anaesthesia should be administered 12 hours AFTER the last dose of VTE prophylaxis VTE prophylaxis should be administered no earlier than 6 hours after regional anaesthesia and subsequent doses should be administered daily. Mechanical VTE prophylaxis Adequate hydration and early mobilisation reduces the risk of VTE 6. There is little evidence that mechanical VTE prophylaxis provides added benefit to pharmacological prophylaxis, but intermittent pneumatic compression (IPC) reduces VTE risk in comparison to no prophylaxis 7. Uncontrolled document when printed Updated/Formatted: (19/02/2015) Approved by QSC on 16/02/2015 Page 5 of 6
Appendix 1 Risk Stratification and Recommended VTE Prophylaxis Mechanical VTE prophylaxis (such as graduated compression stockings (GCS) or IPC) is recommended for women who have contraindications to pharmacological VTE prophylaxis or as an adjunctive therapy in women with a high risk of VTE. Mechanical VTE prophylaxis must be prescribed or initiated on the medicines chart. GCS must be measured and fitted for each woman and should be worn continuously Ideally IPC should begin at induction of anaesthesia and continue post-operatively unless contraindicated. Step 4: Review the patient Duration of dalteparin for VTE prophylaxis The decision regarding the duration of prophylaxis should be made for each patient individually. Generally, VTE prophylaxis is recommended to be continued until the patient is fully mobile or for 7-10 days following gynaecology/oncology surgery and 5-7 days following caesarean birth. High-risk patients: Obstetric patients consider VTE prophylaxis for up to 6 weeks after birth 2,8. Women undergoing major abdominal/pelvic surgery for cancer with other risk factors may require extended duration of VTE prophylaxis up to 4 weeks from discharge 2,14. For women who developed ovarian hyper-stimulation syndrome while undergoing assisted reproduction, consider VTE prophylaxis for up to 3 months post resolution of the syndrome 2. Uncontrolled document when printed Updated/Formatted: (19/02/2015) Approved by QSC on 16/02/2015 Page 6 of 6