Status:
UNKNOWN
rFVIIa in ICH in Patients Treated With Anticoagulants or Anti-Platelets
Lead Sponsor:
University Of Perugia
Conditions:
Intracerebral Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 a...
Detailed Description
Intracerebral hemorrhage (ICH) is the deadliest, most disabling, and least treatable form of stroke. Approximately 40% of patients die within 1 month of ICH onset, and two-thirds of survivors never re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00222625
Start Date
September 1 2005
End Date
September 1 2006
Last Update
September 20 2006
Active Locations (9)
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1
A.O.R.N. San Sebastiano
Caserta, Italy
2
Emergency Room
Forlì, Italy
3
Emergency Department - S.Martino Hospital
Genoa, Italy
4
Emergency Room - University of Messina
Messina, Italy