This trial is conducted in Asia, Europe, Middle East, North America, Oceania, and South America.
The purpose of this study is to evaluate the treatment of Recombinant Factor VIIa (eptacog alfa (activated)) in patients with acute intracerebral bleeding. It is expected that more patients will recover without severe permanent disability after acute treatment with Recombinant Factor VIIa by reducing further intracerebral bleeding.
- Recombinant Factor VIIa (NovoSeven)Drug
Intervention Desc: Coagulation factor. Enhances local hemostasis when it binds to tissue factor
- Activated recombinant human factor VII Drug
- Eptacog alfa (activated) Drug
- Allocation: Randomized
- Masking: Double Blind (Subject, Investigator)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
Patients will be randomised to one of three treatment arms: placebo, and rFVIIa 20 or 80 mcg/kg. Assigned treatment will be administered no more than 4 hours after symptom onset, and no more than 1 hour after baseline CT scan.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Reducing disability and improving clinical outcome after 3 months.|
|Secondary||Reducing hematoma growth and mortality.|
|Primary||Reducing disability and improving clinical outcome||After 3 months||No|
|Secondary||Reducing hematoma growth||No|