- * Male and female subjects ≥ 18 years
- * Subjects who have received oral vitamin K-antagonist therapy
- * Subjects who have acute major bleeding, defined as one of the following: life-threatening or potentially life-threatening, acute bleeding associated with a fall in hemoglobin (Hb) level ≥ 2g/dL, bleeding requiring blood product transfusion
- * INR ≥ 2 within 3 hours before start of study treatment
- * Informed consent has been obtained
Blood Coagulation Disorders
Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy
NCT00708435 | 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 coumarin derivatives in subjects who require immediate correction of INR (International Normalized Ratio)and to stop an acute major bleeding.
Trial Information
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Study Site
Birmingham,Alabama,United States,35248
Study Site
Los Angeles,California,United States,90033
Study Site
San Franciso,California,United States,94115
Study Site
Newark,Delaware,United States,19718
Study Site
Orlando,Florida,United States,32806
Study Site
Tampa,Florida,United States,33606
Study Site
Chicago,Illinois,United States,60612
Study Site
Oak Park,Illinois,United States,60302
Study Site
Hazard,Kentucky,United States,41701
Study Site
Baltimore,Maryland,United States,21201
Study Site
Baltimore,Maryland,United States,21205
Study Site
Boston,Massachusetts,United States,02114
Study Site
Worchester,Massachusetts,United States,01655
Study Site
Ann Arbor,Michigan,United States,48106
Study Site
Royal Oak,Michigan,United States,48073
Study Site
Duluth,Minnesota,United States,55805
Study Site
Minneapolis,Minnesota,United States,55114
Study Site
Jackson,Mississippi,United States,39216
Study Site
St. Louis,Missouri,United States,63110
Study Site
Albuquerque,New Mexico,United States,87131
Study Site
Albany,New York,United States,12208
Study Site
Johnson City,New York,United States,13790
Study Site
New York,New York,United States,10003
Study Site
New York,New York,United States,10029
Study Site
New York,New York,United States,10032
Study Site
Rochester,New York,United States,14642
Study Site
Staten Island,New York,United States,10305
Study Site
Durham,North Carolina,United States,27710
Study Site
Allentown,Pennsylvania,United States,18103
Study Site
Hershey,Pennsylvania,United States,17033
Study Site
Philadelphia,Pennsylvania,United States,19107
Study Site
Philadelphia,Pennsylvania,United States,19140
Study Site
West Reading,Pennsylvania,United States,19611
Study Site
Austin,Texas,United States,78701
Study Site
El Paso,Texas,United States,79905
Study Site
Houston,Texas,United States,77030
Study Site
Houston,Texas,United States,77030
Study Site
Temple,Texas,United States,76508
Study Site
Salt Lake City,Utah,United States,84132
Study Site
Charlottesville,Virginia,United States,22908
Study Site
Richmond,Virginia,United States,23298
Study Site
Minsk,Belarus
Study Site
Minsk,Belarus
Study Site
Pleven,Bulgaria
Study Site
Plovdiv,Bulgaria
Study Site
Rousse,Bulgaria
Study Site
Sofia,Bulgaria
Study Site
Sofia,Bulgaria
Study Site
Sofia,Bulgaria
Study Site
Sofia,Bulgaria
Study Site
Brasov,Romania
Study Site
Bucharest,Romania
Study Site
Bucharest,Romania
Study Site
Bucharest,Romania
Study Site
Cluj-Napoca,Romania
Study Site
Timisoara,Romania
Study Site
Arkhangelsk,Russian Federation
Study Site
Barnaul,Russian Federation
Study Site
Barnaul,Russian Federation
Study Site
Kazan,Russian Federation
Study Site
Kemerovo,Russian Federation,650002
Study Site
Moscow,Russian Federation
Study Site
Moscow,Russian Federation
Study Site
Nizhny Novgorod,Russian Federation
Study Site
Nizhny Novgorod,Russian Federation
Study Site
St. Petersburg,Russian Federation
Study Site
St. Petersburg,Russian Federation
Study Site
Kharkov,Ukraine
Study Site
Vinnytsa,Ukraine
Study Eligibility Criteria
Additional Studies
Additional studies can be found at ClinicalTrials.gov