Recombinant Factor VIIa in Acute Intracerebral Haemorrhage "FAST"

Completed

Phase 3 Results

Results

Treatment with 80 µg of rFVIIa per kilogram resulted in a significant reduction in growth in volume of the hemorrhage. The mean estimated increase in volume of the intracerebral hemorrhage at 24 hours was 26% in the placebo group, as compared with 18% in the group receiving 20 µg of rFVIIa per kilogram (P=0.09) and 11% in the group receiving 80 µg (P<0.001). The growth in volume of intracerebral hemorrhage was reduced by 2.6 ml (95% confidence interval [CI], –0.3 to 5.5; P=0.08) in the group receiving 20 µg of rFVIIa per kilogram and by 3.8 ml (95% CI, 0.9 to 6.7; P=0.009) in the group receiving 80 µg, as compared with the placebo group. Despite this reduction in bleeding, there was no significant difference among the three groups in the proportion of patients with poor clinical outcome (24% in the placebo group, 26% in the group receiving 20 µg of rFVIIa per kilogram, and 29% in the group receiving 80 µg). The overall frequency of thromboembolic serious adverse events was similar in the three groups; however, arterial events were more frequent in the group receiving 80 µg of rFVIIa than in the placebo group (9% vs. 4%, P=0.04). In conclusion,hemostatic therapy with rFVIIa reduced growth of the hematoma but did not improve survival or functional outcome after intracerebral hemorrhage.