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

Summary

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.

Timeline

Start

2009-02

Primary completion

2012-11

Completion

2013-02

Outcome

Met primary endpoint

paper Effective haemostasis was achieved in 78 (90%) patients in the 4F-PCC group compared with 61 (75%) patients in the plasma group PMID 25728933 ↗

paper demonstrating both non-inferiority and superiority of 4F-PCC over plasma (difference 14·3%, 95% CI 2·8-25·8). PMID 25728933 ↗

Publications

• Results Goldstein JN, Refaai MA, Milling TJ Jr, Lewis B, Goldberg-Alberts R, Hug BA, Sarode R. Four-factor prothrombin complex concentrate versus plasma for rapid vitamin K antagonist reversal in patients needing urgent surgical or invasive interventions: a phase 3b, open-label, non-inferiority, randomised trial. Lancet. 2015 May 23;385(9982):2077-87. doi: 10.1016/S0140-6736(14)61685-8. Epub 2015 Feb 27.
• Kincaid M, Young AJ, Dybdahl D, Taylor BC. Effectiveness of Four-Factor Prothrombin Complex Concentrate Versus Plasma in Patients on Vitamin K Antagonists Undergoing Urgent Orthopedic Surgery: A Post Hoc Analysis. Adv Ther. 2026 Jun;43(6):2783-2794. doi: 10.1007/s12325-026-03561-z. Epub 2026 Mar 30.
• Refaai MA, Goldstein JN, Lee ML, Durn BL, Milling TJ Jr, Sarode R. Increased risk of volume overload with plasma compared with four-factor prothrombin complex concentrate for urgent vitamin K antagonist reversal. Transfusion. 2015 Nov;55(11):2722-9. doi: 10.1111/trf.13191. Epub 2015 Jul 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Beriplex	Unknown	—	Intravenous
Comparator	Fresh Frozen Plasma	Protein / enzyme biologic	—	Intravenous

Indications

No indication recorded.