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: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS Policlinico S. Matteo

Criteria

Inclusion Criteria:

• Male or female, aged 18-75 years inclusive

• Intraparenchymal primary supratentorial intracerebral hemorrhage requiring surgical evacuation

• Any Glasgow Coma Score (GCS) score

• Surgery expected to be performed within 24 hours from symptoms onset

Exclusion Criteria:

• Age below 18

• Intraparenchymal hematoma secondary to rupture of cerebral aneurysm or bleeding of arteriovenous (A-V) malformation or cerebral tumors

• Contemporary involvement in another study

• Pregnancy

• Myocardial infarction in the six months preceding enrolment

• Coronary or carotid stents positioned in the six months preceding enrolment

• Solid organ transplant patients (e.g., heart, lung, liver, kidney)

• Pregnancy

• Myocardial infarction in the six months preceding enrolment

• Coronary and carotid stents positioned in the six months preceding enrolment

• Solid organ transplant patients (e.g., heart, lung, liver, kidney)