Last reviewed · How we verify
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 Coumarin Derivatives in Subjects With Acute Major Bleeding
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 coumarin derivatives in subjects who require immediate correction of INR (International Normalized Ratio)and to stop an acute major bleeding.
Details
| Lead sponsor | CSL Behring |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 216 |
| Start date | 2008-06 |
| Completion | 2010-11 |
Conditions
- Blood Coagulation Disorders
- Acute Major Bleeding
Interventions
- Beriplex® P/N (Kcentra)
- Fresh frozen plasma
Primary outcomes
- Percentage of Participants Achieving Hemostatic Efficacy of Stopping an Ongoing Major Bleed — At 1 and 4 hours after the end of infusion
Hemostatic efficacy was determined by a blinded independent board as excellent, good, or poor/none, based on prespecified definitions. Assessments of visible or non-visible musculoskeletal bleeding were made at 1 and 4 hours after the end of infusion. 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 International Normalized Ratio (INR) — 30 minutes after end of infusion
A rapid decrease of the international normalized ratio (INR) was defined as an INR ≤ 1.3 at 30 minutes after the end of the 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, Romania, Russia, Ukraine