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PJ Online homeThe Pharmaceutical Journal
Vol 274 No 7339 p263
5 March 2005

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Factor VII improves outcome in stroke

Patients with intracerebral haemorrhage, a cause of stroke, have improved clinical outcomes if they receive early treatment with the haemostatic agent recombinant activated factor VII.

Researchers treated 399 patients with placebo or factor VII (40, 80 or 160mg/kg) within four hours of intracerebral haemorrhage onset and found that haematoma expansion was retarded among patients in the active treatment group. Haematoma volume increased by 29 per cent in patients given placebo and by 16 per cent, 14 per cent and 11 per cent in the factor VII groups, respectively (P=0.01 for active treatment vs placebo).

At three months follow up there was a 16 per cent absolute reduction in the risk of death or severe disability for factor VII-treated patients.

The researchers acknowledge that the mechanism by which factor VII stops bleeding in these patients is not fully understood. “It seems most likely that the administration of [factor VII] after intracerebral haemorrhage accelerates thrombosis within ruptured small penetrating arteries or arterioles,” they say.

Adverse events, such as myocardial ischaemic events and cerebral infarction, were more common among treated patients but most patients recovered (New England Journal of Medicine 2005;352:777).

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