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.


METHODS
Double-blind randomized trial.


METHODS
Seven Canadian university-affiliated hospitals.


METHODS
Eighty-seven patients with acute ischemic stroke resulting in lower-limb paresis.


METHODS
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.


METHODS
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% CI, 16% to 93%. The corresponding rates for proximal vein thrombosis were 4% and 12%, respectively (relative risk reduction, 63%; P greater than 0.2). The incidence of hemorrhage was 2% in both groups.


CONCLUSIONS
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.
Turpie
A G
AG
McMaster University, Hamilton, Ontario, Canada.
Gent
M
M
Côte
R
R
Levine
M N
MN
Ginsberg
J S
JS
Powers
P J
PJ
Leclerc
J
J
Geerts
W
W
Jay
R
R
Neemeh
J
J
D000208:Acute Disease; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000990:Antithrombin III / Q000187:drug effects; D002545:Brain Ischemia / Q000150:complications*; D002809:Chondroitin Sulfates; D003871:Dermatan Sulfate; D004311:Double-Blind Method; D005260:Female; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006025:Glycosaminoglycans / Q000009:adverse effects / Q000627:therapeutic use*; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000009:adverse effects / Q000627:therapeutic use*; D006497:Heparan Sulfate; D006801:Humans; D008297:Male; D008875:Middle Aged; D013924:Thrombophlebitis / Q000150:complications / Q000517:prevention & control*
D000990:Antithrombin III; D002809:Chondroitin Sulfates; D003871:Dermatan Sulfate; D005343:Fibrinolytic Agents; D006025:Glycosaminoglycans; D006493:Heparin; D006497:Heparan Sulfate; C035838:danaparoid