Status:
TERMINATED
Factor VII, Prothrombin Complex Concentrate, and Fresh Frozen Plasma in Warfarin-Related Intracranial Hemorrhage
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Sheila B. Terry Memorial Research Fund
Conditions:
Intracranial Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this dose-ranging pilot study is to compare Recombinant Activated Factor VII, Prothrombin Complex Concentrate and Fresh Frozen Plasma (each starting at low doses with escalation if nece...
Detailed Description
Both recombinant activated Factor VIIa (rFVIIa) as well as Prothrombin Complex Concentrate (PCC) are labeled for the treatment of bleeding episodes in patients with hemophilia. Many hospitals are also...
Eligibility Criteria
Inclusion
- Non-traumatic intracranial hemorrhage (subdural or intraparenchymal)
- Known warfarin ingestion
- INR ≥2.0
- GCS \<13
Exclusion
- Pregnancy
- History of venous thrombosis or pulmonary embolus
- Acute myocardial infarction
- Acute stroke
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00770718
Start Date
April 1 2008
End Date
April 1 2010
Last Update
November 24 2011
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