Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage.
Publication/Presentation Date
5-15-2008
Abstract
BACKGROUND: Intracerebral hemorrhage is the least treatable form of stroke. We performed this phase 3 trial to confirm a previous study in which recombinant activated factor VII (rFVIIa) reduced growth of the hematoma and improved survival and functional outcomes.
METHODS: We randomly assigned 841 patients with intracerebral hemorrhage to receive placebo (268 patients), 20 microg of rFVIIa per kilogram of body weight (276 patients), or 80 microg of rFVIIa per kilogram (297 patients) within 4 hours after the onset of stroke. The primary end point was poor outcome, defined as severe disability or death according to the modified Rankin scale 90 days after the stroke.
RESULTS: Treatment with 80 microg 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 microg of rFVIIa per kilogram (P=0.09) and 11% in the group receiving 80 microg (P
CONCLUSIONS: Hemostatic therapy with rFVIIa reduced growth of the hematoma but did not improve survival or functional outcome after intracerebral hemorrhage. (ClinicalTrials.gov number, NCT00127283 [ClinicalTrials.gov].).
Volume
358
Issue
20
First Page
2127
Last Page
2137
ISSN
1533-4406
Published In/Presented At
Mayer, S. A., Brun, N. C., Begtrup, K., Broderick, J., Davis, S., Diringer, M. N., Skolnick, B. E., Steiner, T., & FAST Trial Investigators (2008). Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage. The New England journal of medicine, 358(20), 2127–2137. https://doi.org/10.1056/NEJMoa0707534
Disciplines
Medicine and Health Sciences
PubMedID
18480205
Department(s)
Department of Medicine
Document Type
Article