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A Low-Molecular-Weight Heparinoid Compared with Unfractionated Heparin in the Prevention of Deep Vein Thrombosis in Patients with Acute Ischemic Stroke
A Randomized, Double-Blind Study
- Alexander G.G. Turpie, MD;
- Michael Gent, DSc;
- Robert Côte, MD;
- Mark N. Levine, MD;
- Jeffrey S. Ginsberg, MD;
- Peter J. Powers, MD;
- Jacques Leclerc, MD;
- William Geerts, MD;
- Richard Jay, MD;
- Jean Neemeh, MD;
- Marian Klimek, BScN; and
- Jack Hirsh, MD
Abstract
▪ Objective: To compare the relative safety and efficacy of a low-molecular-weight heparinoid (ORG 10172) with unfractionated heparin in the prevention of deep vein thrombosis in patients with acute ischemic stroke.
▪ Design: Double-blind randomized trial.
▪ Setting: Seven Canadian university-affiliated hospitals.
▪ Participants: Eighty-seven patients with acute ischemic stroke resulting in lower-limb paresis.
▪ Intervention: Patients received either low-molecular-weight heparinoid, 750 anti-factor Xa units twice daily, or unfractionated heparin, 5000 units subcutaneously twice daily. Treatment was continued for 14 days or until hospital discharge if sooner.
▪ Measurements: Deep vein thrombosis was diagnosed using 125I-labeled fibrinogen leg scanning and impedance plethysmography. Venography was indicated if either test was positive. Overt hemorrhage, major or minor, was assessed clinically.
▪ Results: Venous thrombosis occurred in four patients (9%) given low-molecular-weight heparinoid and in 13 patients (31%) given heparin (relative risk reduction, 71%; 95% Cl, 16% to 93%. The corresponding rates for proximal vein thrombosis were 4% and 12%, respectively (relative risk reduction, 63%; P > 0.2). The incidence of hemorrhage was 2% in both groups.
▪ Conclusion: Low-molecular-weight heparinoid, given in a fixed dose of 750 anti-factor Xa units subcutaneously twice daily, is more effective than subcutaneous low-dose heparin for the prevention of deep vein thrombosis in patients with acute ischemic stroke.
Article and Author Information
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From McMaster University and the Hamilton Civic Hospitals Research Centre, Hamilton, Ontario, McGill University, Montreal, Quebec, and Université de Montréal, Québec, Canada. For current author addresses, see end of text.
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Grant Support: In part by a grant-in-aid from Organon International BV, Oss, The Netherlands, and by the Hamilton Civic Hospitals Research Centre, Hamilton, Ontario, Canada. Dr. Hirsh is a Distinguished Professor of the Heart and Stroke Foundation of Ontario. The study was performed and monitored independent of Organon.
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Requests for Reprints: A.G.G.Turpie, MD, HGH-McMaster Clinic, Hamilton Civic Hospitals, General Division, 237 Barton Street East, Hamilton, Ontario, Canada L8L 2X2.
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Current Author Addresses: Dr. Turpie: HGH-McMaster Clinic, Hamilton Civic Hospitals, General Division, 237 Barton Street East, Hamilton, Ontario, Canada L8L 2X2.
Drs. Gent, Levine, Hirsh, and Ms. Klimek: Hamilton Civic Hospitals Research Centre, 711 Concession Street, Hamilton, Ontario, Canada L8V 1C3.
Drs. Côte and Leclerc: Montreal General Hospital, 1650 Cedar Avenue, Montreal, Quebec, Canada H3G 1A4.
Dr. Ginsberg: McMaster University Medical Centre, 3W12, 1200 Main Street West, Hamilton, Ontario, Canada L8N 3Z5.
Dr. Powers: St. Joseph's Hospital, 50 Charlton Avenue East, Hamilton, Ontario, Canada L8N 4A6.
Drs. Geerts and Jay: Sunnybrook Health Sciences Centre, 2075 Bayview Avenue, Toronto, Ontario, Canada M4N 3M5.
Dr. Neemeh: Centre Hospitalier Sainte-Jeanne-d'Arc, 3570 rue Saint-Urbain, Montreal, Quebec, Canada H2X 2N8.
- ©1992 American College of Physicians
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