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VTE Prophylaxis Working Group Introduction v_01 Prevention of Venous Thromboembolism (VTE) in Hospitalized Medical and Surgical Patients Purpose The Tinzaparin Prophylaxis Working Group and the development of tinzaparin VTE standing orders and other material found in this package was put together in response to the need expressed by clinical pharmacists as they meet the ROP requirements put forth by Accreditation Canada for VTE prophylaxis using the low molecular weight heparin (LMWH) tinzaparin. Overview VTE is a serious and common complication for patients in hospital or undergoing surgery. Evidence shows that the incidence of VTE can be substantially reduced or prevented by providing appropriate, evidence-based thromboprophylaxis interventions, In Canada, we currently use the American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th edition) as the accepted standard of practice for the prevention of VTE. While these guidelines are comprehensive they do not address specific patient needs/issues for every individual anticoagulant therapy, rather LMWHs are discussed as a class. Specifically the standing order, audit, education and implementation material developed by the Tinzaparin Prophylaxis Working Group was developed to address specific questions regarding the use of tinzaparin for VTE prophylaxis. These questions include appropriate use of thromboprophylaxis, weight-based vs. fixed dosing, appropriate dosing for under- and overweight patients, and dosing in patients with renal impairment or on hemodialysis. In making our recommendations we reviewed the available literature and consulted with Canadian experts who have a significant amount of experience with LMWH and tinzaparin in particular. Members of the Tinzaparin Prophylaxis Working Group Reginald E. Smith, PharmD, ACPR, (Chair) Clinical Pharmacy Specialist, Royal Jubilee Hospital Victoria, BC William Geerts, MD, FRCPC, FCCP, Thromboembolism Specialist, Sunnybrook Health Sciences Centre; Professor of Medicine, University of Toronto, Toronto, ON Artemis Diamantouros, BScPharm, National Coordinator, VTE Prevention, KT Pharmacist, Sunnybrook Health Sciences Centre, Toronto, ON Glenn Whiteway, PharmD, Pharmacy Clinical Manager, Dr. Everett Chalmers Regional Hospital ICU Pharmacist /Horizon Health Network; Adjunct Professor, Dalhousie School of Pharmacy, Fredericton, NB Mary Pederson, BScPharm, Clinical Practise Leader, Chinook Regional Hospital, Alberta Health Services Southwest, Lethbridge, AB VTE Prophylaxis Working Group Introduction v_01 Patrick Robertson, BSP, PharmD, Manager, Department of Pharmaceutical Services, Saskatoon Health Region, Saskatoon, SK William Semchuk, MSc, PharmD, FCSHP, Manager, Clinical Pharmacy Services Regina Qu'Appelle Health Region, Regina General Hospital, Regina, SK Ritesh Mistry, MD, CCFP, Hospitalist, William Osler Health System, Brampton, ON; Clinical Assistant Professor, DeGroote School of Medicine, McMaster University, Hamilton, ON References: Accreditation Canada, Required Organizational Practices, April 2010. Barrett JS, Gibiansky E, Hull RD, Planes A, Pentikis H, Hainer JW et al. Population pharmacodynamics in patients receiving tinzaparin for the prevention and treatment of deep vein thrombosis. Int J Clin Pharmacol Ther 2001;39:431-46. Bergqvist D, Flordal PA, Friberg B, et al. Thromboprophylaxis with a low molecular weight heparin (tinzaparin) in emergency abdominal surgery. A double-blind multicenter trial. Vasa. 1996;25(2):15660. Cestac P, Bagheri H, Lapeyre-Mestre M, Sie P, Fouladi A, Maupas E et al. Utilisation and safety of low molecular weight heparins: prospective observational study in medical inpatients. Drug Saf 2003;26:197-207. Did not use fixed dose. Green D, Chen D, Chmiel JS, Olsen NK, Berkowitz M, Novick A et al. Prevention of thromboembolism in spinal cord injury: role of low molecular weight heparin. Arch Phys Med Rehabil 1994;75:290-2. Green D, Lee MY, Lim AC, Chmiel JS, Vetter M, Pang T et al. Prevention of thromboembolism after spinal cord injury using low-molecular-weight heparin. Ann Intern Med 1990;113:571-4. Hainer JW, Barrett JS, Assaid CA, Fossler MJ, Cox DS, Leathers T et al. Dosing in heavy-weight/obese patients with the LMWH, tinzaparin: a pharmacodynamic study. Thromb Haemost 2002;87:817-23. Hainer JW, Sherrard DJ, Swan SK, Barrett JS, Assaid CA, Fossler MJ et al. Intravenous and subcutaneous weight-based dosing of the low molecular weight heparin tinzaparin (Innohep) in endstage renal disease patients undergoing chronic hemodialysis. Am J Kidney Dis 2002;40:531-8. Had patients between 101-165 kg but used weight based dosing. Noted that weight-adjusted dosing yields predictable response regardless of body weight or BMI. Hauch O, Jørgensen LN, Kølle TR, et al. Low molecular weight heparin (Logiparin) as thromboprophylaxis in elective abdominal surgery. A dose finding study. Acta Chir Scand Suppl. 1988;543:90-5. VTE Prophylaxis Working Group Introduction v_01 Jorgensen PS, Warming T, Hansen K, Paltved C, Vibeke BH, Jensen R et al. Low molecular weight heparin (Innohep) as thromboprophylaxis in outpatients with a plaster cast: a venografic controlled study. Thromb Res 2002;105:477-80. Kuczka K, Baum K, Picard-Willems B, et al. Long term administration of LMWH-pharmacodynamic parameters under therapeutic or prophylactic regimen of enoxaparin or tinzaparin in neurological rehabilitation patients. Thrombosis Research. 2009;124:625-30. Lausen I, Jensen R, Jorgensen LN, et al. Incidence and prevention of deep venous thrombosis occurring late after general surgery: randomised controlled study of prolonged thromboprophylaxis. Eur J Surg. 1998 Sep;164(9):657-63. Liezorovicz A, Picolet H, Peyrieux JC, Boissel JP. Prevention of perioperative deep vein thrombosis in general surgery: a multicentre double blind study comparing two doses of Logiparin and standard heparin. H.B.P.M. Research Group. Br J Surg 1991;78:412-6. Mahe I, Aghassarian M, Drouet L, Bal Dit-Sollier C, Lacut K, Heilmann JJ et al. Tinzaparin and enoxaparin given at prophylactic dose for eight days in medical elderly patients with impaired renal function: a comparative pharmacokinetic study. Thromb Haemost 2007;97:581-6. Myers J. Selecting an agent for prophylaxis of venous thromboembolism. Am J Health-Syst Pharm 2006;2448-50. Nutescu EA, Shapiro NL, Feinstein H, Rivers CW. Tinzaparin: considerations for use in clinical practice. Ann Pharmacother 2003;37:1831-40. Nutescu EA, Spinler SA, Wittkowsky A, Dager WE. Low-molecular-weight heparins in renal impairment and obesity: available evidence and clinical practice recommendations across medical and surgical settings. Ann Pharmacother 2009;43:1064-83. Pahatouridis D, Alexiou GA, Zigouris A, et al. Coagulopathy in moderate head injury. The role of early administration of low molecular weight heparin. Brain Inj. 2010;24(10):1189-92. Pautas E, Gouin I, Bellot O, Andreux JP, Siguret V. Safety profile of tinzaparin administered once daily at a standard curative dose in two hundred very elderly patients. Drug Saf 2002;25:725-33. Planes A, Samama MM, Lensing AW, Buller HR, Barre J, Vochelle N et al. Prevention of deep vein thrombosis after hip replacement--comparison between two low-molecular heparins, tinzaparin and enoxaparin. Thromb Haemost 1999;81:22-5. PROTECT Investigators. Dalteparin versus unfractionated heparin in critically ill patients. N Engl J Med. 2011;364:1305-14. Rodger M, Ramsay T, Mackinnon M, et al. Tinzparin versus dalteparin for peri-procedure thromboembolic prophylaxis in patients with dialysis dependent renal disease. Blood 2009;114(22): Abstract no. 3136