Venous thrombo-
embolism is a common complication in patients with acute
ischaemic stroke. Without prophylaxis,
deep vein thrombosis occurs in 60-75% of patients with dense
hemiplegia, usually in the paralyzed limb, and 1-2% suffer fatal
pulmonary embolism.
Orgaran (
Org 10172, low-molecular-weight
heparinoid) has been evaluated for the prevention of
deep vein thrombosis in patients with acute
ischaemic stroke in two studies. In a double-blind study, 75 patients were randomized to receive
Orgaran (50 patients) in a loading dose of 1,000 anti-Xa units intravenously followed by 750 anti-Xa units subcutaneously 12-hourly or placebo (25 patients).
Deep vein thrombosis occurred in 2 of 50 (4%) in the
Orgaran group and 7 of 25 (28%) in the placebo group (p = 0.005). The corresponding rates for proximal
deep vein thrombosis were 0 and 16%, respectively (p = 0.01). There was one major haemorrhage in the treated group and one minor haemorrhage in the placebo group. In the second study, the safety and efficacy of
Orgaran was compared with
unfractionated heparin in the prevention of
deep vein thrombosis in a double-blind randomized trial. Eighty-seven patients with marked lower limb
paralysis secondary to
stroke were randomized to receive
Orgaran (45 patients) in a dose of 750 anti-
factor Xa units subcutaneously 12-hourly or
unfractionated heparin (42 patients) in a dose of 5,000 units subcutaneously 12-hourly.
Venous thrombosis occurred in 4 of 45 (8.9%) of the
Orgaran group and 13 of 42 (31%) in the
unfractionated heparin group (2p = 0.014). The corresponding rates for proximal vein
thrombosis were 4.4 and 11.9%, respectively (2p = 0.255).(ABSTRACT TRUNCATED AT 250 WORDS)