NCT00803101

An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Reversal of Coagulopathy

Interventions

Type	Name	Description
BIOLOGICAL	Beriplex® P/N (Kcentra)	Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
BIOLOGICAL	Fresh frozen plasma	Intravenous infusion, dosage depending on baseline INR and body weight

Timeline

• Start date: 2009-02-01
• Primary completion: 2012-11-01
• Completion: 2013-02-01
• First posted: 2008-12-05
• Last updated: 2015-04-06
• Results posted: 2014-02-25

Locations

30 sites across 6 countries: United States, Belarus, Bulgaria, Lebanon, Romania, Russia