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

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 I-125-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% CI, 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.