Level 2: Mid-level evidence

A previous study with 400 patients suggested recombinant activated factor VII (rFVIIa) may reduce mortality in patients with acute intracerebral hemorrhage (ICH) (N Engl J Med. 2005;352:777-785), but the recently published Factor Seven for Acute Hemorrhagic Stroke (FAST) trial suggests that rFVIIa does not appear to reduce mortality (N Engl J Med. 2008;358:2127-2137). Patients with spontaneous ICH diagnosed by CT within three hours of onset (N=841) were randomized to rFVIIa 20 µg/kg vs. 80 µg/kg vs. placebo within four hours of stroke onset.

Comparing rFVIIa 20 µg/kg vs. placebo, there were no significant differences in mean estimated increase in clot volume at 24 hours, mortality at 90 days, severe disability (modified Rankin Scale score 5-6) at 90 days, MI or cerebral infarction, or deep venous thrombosis (DVT) or pulmonary embolism (PE).

Comparing rFVIIa 80 µg/kg vs. placebo, rFVIIa was associated with a favorable change in clot volume at 24 hours
(P <.001), but there were no significant differences in mortality at 90 days (21% vs. 19%), severe disability at 90 days (30% vs. 24%), or DVT or PE (2% vs. 4%). Incidence of MI or cerebral infarction was higher with rFVIIa (8% vs. 4%, P = .04, NNH 25).

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