Efficacy and Safety of Factor VIIa on Rebleeding After Surgery for Spontaneous Intracerebral Hemorrhage (ICH)

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 31, 2005

Primary Completion Date

December 31, 2008

Study Completion Date

December 31, 2008

Conditions
Intracerebral Hemorrhage
Interventions
DRUG

rFactor VIIa (Eptacog alfa, NovoNordisk)

rFVIIa will be admistered as single bolus at the dosage of 100 mcg/Kg b.w.

DRUG

rFVIIa

Patients with spontaneous supratentorial ICH will be treated with rFVII after hematoma evacuation

OTHER

Sodiun chloride 0.9%

Bolus injection of sodium chloride 0.9% after surgical hematoma removal

Trial Locations (3)

12100

Azienda Ospedaliera S. Croce e Carle, Cuneo

27100

II Dpt Anesthesiology&Critical Care Medicine - IRCCS Policlinico S. Matteo, Pavia

28100

"Azienda Ospedaliera Maggiore della Carità", Novara

All Listed Sponsors
lead

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

NCT00128050 - Efficacy and Safety of Factor VIIa on Rebleeding After Surgery for Spontaneous Intracerebral Hemorrhage (ICH) | Biotech Hunter | Biotech Hunter