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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
[+] Article, Author, and Disclosure Information

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.

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.

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.

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 PhysiciansAmerican College of Physicians

Ann Intern Med. 1992;117(5):353-357. doi:10.7326/0003-4819-117-5-353
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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.





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