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Reversal of Coagulopathy

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
NCT00803101 | PHASE 3 | INTERVENTIONAL

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.

Trial Information
30 Sites
176 Participants
Recruiting
18 Years to 65 Years

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Study Site
Newark,Delaware,United States,19718
Study site
Lexington,Kentucky,United States,40536
Study Site
Boston,Massachusetts,United States,02114
Study Site
Duluth,Minnesota,United States,55805
Study Site
Minneapolis,Minnesota,United States,55415
Study Site
Albuquerque,New Mexico,United States,87131
Study Site
Rochester,New York,United States,14642
Study Site
Winston-Salem,North Carolina,United States,27157
Study Site
Philadelphia,Pennsylvania,United States,19107
Study Site
West Reading,Pennsylvania,United States,19611
Study Site
Wilkes Barre,Pennsylvania,United States,18711
Study Site
Memphis,Tennessee,United States,38163
Study Site
Austin,Texas,United States,78701
Study site
Bryan,Texas,United States,77802
Study Site
El Paso,Texas,United States,79905
Study Site
Houston,Texas,United States,77030
Study Site
Minsk,Belarus
Study Site
Minsk,Belarus
Study Site
Rousse,Bulgaria,7002
Study Site
Sofia,Bulgaria,1606
Study Site
Varna,Bulgaria,9010
Study Site
Beirut,Lebanon,2833-7401
Study Site
Saida,Lebanon,652
Study Site
Timisoara,Romania,300736
Study Site
Barnaul,Russian Federation,656038
Study Site
Kazan,Russian Federation,420012
Study Site
Moscow,Russian Federation,105203
Study Site
Moscow,Russian Federation,125206
Study Site
Novosibirsk,Russian Federation,630051
Study Site
Saint Petersburg,Russian Federation,192242

Study Eligibility Criteria

Additional Studies

Additional studies can be found at ClinicalTrials.gov