Efficacy and Safety of a 4-Factor Prothrombin Complex Concentrate in Patients on Vitamin K Antagonists Presenting With Major Bleeding
University of Rochester Medical Center · Massachusetts General Hospital · +3 more institutions
Abstract
BACKGROUND: Patients experiencing major bleeding while taking vitamin K antagonists require rapid vitamin K antagonist reversal. We performed a prospective clinical trial to compare nonactivated 4-factor prothrombin complex concentrate (4F-PCC) with plasma for urgent vitamin K antagonist reversal. METHODS AND RESULTS: In this phase IIIb, multicenter, open-label, noninferiority trial, nonsurgical patients were randomized to 4F-PCC (containing coagulation factors II, VII, IX, and X and proteins C and S) or plasma. Primary analyses examined whether 4F-PCC was noninferior to plasma for the coprimary end points of 24-hour hemostatic efficacy from start of infusion and international normalized ratio correction…
Citation impact
- FWCI
- 50.38
- Percentile
- 100%
- References
- 43
Authors
7- RSRavi SarodeCorresponding
University of Rochester Medical Center, Massachusetts General Hospital, Behringwerke (Germany), CSL (United States), The University of Texas Southwestern Medical Center
- TJTruman J. Milling
University of Rochester Medical Center, Massachusetts General Hospital, Behringwerke (Germany), CSL (United States), The University of Texas Southwestern Medical Center
- MAMajed A. Refaai
University of Rochester Medical Center, Massachusetts General Hospital, Behringwerke (Germany), CSL (United States), The University of Texas Southwestern Medical Center
- AMAntoinette Mangione
University of Rochester Medical Center, Massachusetts General Hospital, Behringwerke (Germany), CSL (United States), The University of Texas Southwestern Medical Center
- ASAstrid Schneider
University of Rochester Medical Center, Massachusetts General Hospital, Behringwerke (Germany), CSL (United States), The University of Texas Southwestern Medical Center
Topics & keywords
- Medicine
- Vitamin K antagonist
- Prothrombin complex concentrate
- Confidence interval
- Hemostasis
- Adverse effect
- Internal medicine
- Population