Double-blind randomised trial of Org 10172 low-molecular-weight heparinoid in prevention of deep-vein thrombosis in thrombotic stroke.
In a double-blind, randomised trial Org 10172 low-molecular-weight (LMW) heparinoid was compared with placebo in the prevention of deep-vein thrombosis in patients with acute thrombotic stroke. Prophylaxis was started within 7 days of the onset of stroke with a loading dose of 1000 anti-factor-Xa units intravenously followed by a fixed dose of 750 anti-factor-Xa units twice a day subcutaneously; it was continued for 14 days or until hospital discharge, if earlier. 50 patients were randomised to receive Org 10172 and 25 to receive placebo. All patients underwent surveillance with I125-fibrinogen leg scanning and impedance plethysmography. Venography was carried out if either test became positive. Venous thrombosis occurred in 2 of 50 patients (4.0%) given Org 10172 and 7 of 25 patients (28.0%) given placebo (p = 0.005); the corresponding rates of proximal-vein thrombosis were 0% and 16%, respectively (p = 0.01). There was one major haemorrhage in the Org 10172 group and one minor bleed in the placebo group.
D000208:Acute Disease; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002561:Cerebrovascular Disorders / Q000150:complications*; D002809:Chondroitin Sulfates; D002986:Clinical Trials as Topic; D003871:Dermatan Sulfate; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006025:Glycosaminoglycans / Q000008:administration & dosage / Q000627:therapeutic use*; D006493:Heparin / Q000097:blood; D006496:Heparinoids / Q000008:administration & dosage / Q000627:therapeutic use*; D006497:Heparan Sulfate; D006801:Humans; D007275:Injections, Intravenous; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D011859:Radiography; D011897:Random Allocation; D013927:Thrombosis / Q000000981:diagnostic imaging / Q000517:prevention & control*; D013997:Time Factors
D002809:Chondroitin Sulfates; D003871:Dermatan Sulfate; D005343:Fibrinolytic Agents; D006025:Glycosaminoglycans; D006493:Heparin; D006496:Heparinoids; D006497:Heparan Sulfate; C035838:danaparoid