Clinical trials: Anticoagulant-induced Bleeding
Blood Coagulation Disorders, Acute Major Bleeding
Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy
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…
- Trial name
- NCT00708435
- Testing
- Beriplex® P/N (Kcentra), Fresh frozen plasma
- Where
- 69 sites in United States, Belarus and 4 more
- Volunteers
- 216 people
- Sponsor
- CSL Behring
Significant Bleeding Risk
Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.
To demonstrate that the efficacy of OCTAPLEX as a reversal agent in patients under Vitamin K Antagonist (VKA) therapy with the need for urgent surgery with significant bleeding risk is clinically non-inferior to that Beriplex®…
- Trial name
- NCT02740335
- Testing
- Octaplex, Beriplex P/N (Kcentra)
- Where
- 86 sites in United States, Belarus and 9 more
- Volunteers
- 208 people
- Sponsor
- Octapharma