Status:
COMPLETED
Efficacy and Safety of Factor VIIa on Rebleeding After Surgery for Spontaneous Intracerebral Hemorrhage (ICH)
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions:
Intracerebral Hemorrhage
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 hem...
Detailed Description
The primary endpoint is the evaluation of efficacy of Factor VIIa (Eptacog alfa, NovoSeven, Novo Nordisk) on rebleeding after surgery for primary supratentorial ICH. All patients included in the study...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00128050
Start Date
January 1 2005
End Date
December 1 2008
Last Update
February 4 2009
Active Locations (3)
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1
Azienda Ospedaliera S. Croce e Carle
Cuneo, Cuneo, Italy, 12100
2
Azienda Ospedaliera "Maggiore della Carità"
Novara, Italy, 28100
3
II Dpt Anesthesiology&Critical Care Medicine - IRCCS Policlinico S. Matteo
Pavia, Italy, 27100