Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Parallel Groups, Study to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (NovoSeven®) in Acute Intracerebral Haemorrhage

This trial is conducted in North America, Europe, Asia and Oceania. The purpose of this study is to evaluate safety and efficacy of Recombinant Factor VIIa in patients with acute intracerebral bleeding.

Inclusion Criteria:

• Spontaneous intracranial haemorrhage (ICH) within 3 hours after first symptom

Exclusion Criteria:

• Patients with secondary ICH
• Pre-existing disability
• Haemophilia