Experiences with an activated 4-factor prothrombin complex concentrate (FEIBA) for reversal of warfarin-related bleeding.

BACKGROUND

Current reversal options for warfarin-related bleeding are limited but include fresh frozen plasma, recombinant factor VIIa, or a prothrombin complex concentrate (PCC). There are little data discussing the use of activated 4-factor PCC for warfarin reversal.

OBJECTIVES

This review will summarize our experiences with FEIBA (Baxter, Deerfield, IL), an activated 4-factor PCC, for the reversal of warfarin-related bleeding in a community hospital.

METHODS

A protocol was put in place in March of 2011, which outlined the use of FEIBA for the emergent reversal of warfarin-related coagulopathy. A low fixed dose was given based on international normalized ratio (INR). For an INR less than 5.0, 500 U of FEIBA was administered. For an INR greater than or equal to 5.0, 1000 U of FEIBA was given. Intravenous vitamin K was given concurrently regardless of INR.

RESULTS

Sixteen patients were treated with FEIBA per the protocol. Average patient age was 73 years. Intracranial hemorrhage was the most common indication for reversal. Mean pre-treatment INR was 3.56 (1.3-6.8); mean post-treatment INR was 1.16 (1.01-1.32). Two of the patients required a second 500-U dose, per the protocol, for an INR that had not yet normalized. Bleeding appeared clinically controlled in 93% of cases. Eighty-seven percent of patients survived to discharge. There were no signs or symptoms of thrombosis in any of the cases.

CONCLUSIONS

Emergent reversal of warfarin utilizing a fixed, low dose of FEIBA appears to be efficacious, consistent, and safe. Further comparator studies with other reversal agents are needed.