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

• Status: Unknown status
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of efficacy and safety of recombinant factor VIIa versus standard therapy in preventing early haematoma growth in spontaneous acute intracerebral haemorrhage in patients treated with oral anticoagulants or antiplatelets agents

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Of Perugia
• Treatments: Anticoagulants; Platelet Aggregation Inhibitors

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.