Efficacy and Safety of Factor VIIa on Rebleeding After Surgery for Spontaneous Intracerebral Hemorrhage (ICH)
Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
Although the role of surgical treatment is still controversial, surgical evacuation of
intracerebral hematoma is a frequent practice. Rebleeding is a frequent complication in
patients submitted to hematoma evacuation. It has been reported that smaller postoperative
volume of hematoma is associated with a better outcome. The investigators hypothesize that
the administration of Factor VIIa (Eptacog alfa) immediately after surgical evacuation of the
hematoma can reduce postoperative rebleeding.
Aims of the Study:
This study will investigate:
1. The efficacy of Eptacog alfa in preventing or reducing rebleeding after surgery for
spontaneous supratentorial ICH; and
2. The safety of product administration