Factor VII, Prothrombin Complex Concentrate, and Fresh Frozen Plasma in Warfarin-Related Intracranial Hemorrhage

• Status: Terminated
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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 necessary) for the reversal of warfarin in the setting of acute intracranial hemorrhage.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Utah
• Collaborator: Sheila B. Terry Memorial Research Fund
• Treatments: Thrombin; Warfarin

Criteria

Inclusion Criteria:

• Non-traumatic intracranial hemorrhage (subdural or intraparenchymal)

• Known warfarin ingestion

• INR ≥2.0

• GCS <13

Exclusion Criteria:

• Pregnancy

• History of venous thrombosis or pulmonary embolus

• Acute myocardial infarction

• Acute stroke