Clinical trials: Reversal of Coagulopathy
Acute Bleeding on Long-Term Anticoagulation Therapy, Hemorrhage
Fixed Versus Variable Dosing of 4-factor Prothrombin Complex Concentrate for Emergent Warfarin Reversal
The goal of this study is to determine if a fixed dose of 4-factor prothrombin complex concentrate (4FPCC) is as effective as the current standard of care.
- Conditions
- Acute Bleeding on Long-Term Anticoagulation Therapy, Hemorrhage, Significant Bleeding in Patients With a Coagulopathy (Prolonged Thrombin Time), Urgent Reversal of Vitamin K Antagonist (VKA) Anticoagulation
- Trial name
- kcentra (NCT03064035)
- Testing
- 4-factor prothrombin complex concentrate (4FPCC)
- Where
- United States
- Volunteers
- 79 people
- Sponsor
- HealthPartners Institute
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
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…
- Trial name
- BE1116_3003 (NCT00803101)
- Testing
- Beriplex® P/N (Kcentra), Fresh frozen plasma
- Where
- 30 sites in United States, Belarus and 4 more
- Volunteers
- 176 people
- Sponsor
- CSL Behring