drugset / Trial / NCT00770718
Factor VII, Prothrombin Complex Concentrate, and Fresh Frozen Plasma in Warfarin-Related Intracranial Hemorrhage
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2008-04
- Primary completion
- 2010-04
- Completion
- 2010-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fresh Frozen Plasma | Protein / enzyme biologic | — | — |
| Subject | Prothrombin Complex Concentrate | Protein / enzyme biologic | 30 iu/kg | — |
| Subject | eptacog alfa (activated) | Protein / enzyme biologic | 1 mg | Intravenous |