rFVIIa in ICH in Patients Treated With Anticoagulants or Anti-Platelets


Phase 2 Results N/A

Eligibility Criteria

Inclusion Criteria

- ICH in patient on treatment with one of the following:
- a)oral anticoagulant (INR upper than 1,4 at enrollment
- b) aspirin, whatever dosage
- Male or female subjects, age > 18 years.
- Informed consent

Exclusion Criteria

- INR below 1.4 for patients on oral anticoagulants.
- Patients with secondary ICH related to infarction, tumor, cerebrovenous thrombosis, thrombolysis.
- Planned neurosurgical intervention.
- Any history of haemophilia or other congenital or acquired coagulopathy requiring specific antihemorrhagic treatment.
- Acute myocardial ischaemia or acute thrombotic stroke (within one year).
- Septicemia, intravascular disseminated coagulation.
- Pregnancy.
- Limb amputation due to vascular disease or claudication within last 30 days.
- Known or suspected allergy to the trial product or related products.
- Participation in other trials within the previous year.