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An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure (BE1116_3003)
The purpose of this study is to evaluate efficacy, safety and tolerance of Beriplex® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by vitamin K antagonists in subjects who require immediate correction of international normalized ratio (INR) because of emergency surgery.
Details
| Lead sponsor | CSL Behring |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 176 |
| Start date | 2009-02 |
| Completion | 2013-02 |
Conditions
- Reversal of Coagulopathy
Interventions
- Beriplex® P/N (Kcentra)
- Fresh frozen plasma
Primary outcomes
- Percentage of Participants Achieving Hemostatic Efficacy During Surgery — From the start of infusion until the end of surgery
Hemostatic efficacy was rated as excellent, good, or poor/none, based on prespecified definitions. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where 'effective' was a hemostatic efficacy rating of "excellent" or "good," and 'non-effective' was a hemostatic efficacy rating of "poor/none". - Percentage of Participants Who Had a Rapid Decrease of the INR — 30 minutes after the end of infusion
A rapid decrease of the INR was defined as an INR ≤ 1.3 at 30 minutes after the end of infusion. The INR is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy.
Countries
United States, Belarus, Bulgaria, Lebanon, Romania, Russia