Fixed-dose Activated Versus Variable-dose Inactivated Prothrombin Complex Concentrate for Warfarin-associated Major Bleed

• Status: Completed
• Trial end date: 2016-09-30
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to assess a fixed-dose regimen of activated prothrombin complex concentrate (FEIBA VH, Baxter) versus the variable, manufacturer recommended, dose regimen of inactivated prothrombin complex concentrate (Kcentra, CSL Behring) for reversal of warfarin-associated major hemorrhage.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rush University Medical Center
• Collaborator: Advocate Health Care
• Treatments: Anti-inhibitor coagulant complex; Thrombin; Warfarin

Criteria

Inclusion Criteria:

• Pre-treatment INR lab value greater than 1.5

• Receipt of treatment with a 4-factor PCC for INR normalization due to warfarin-associated major hemorrhage

Exclusion Criteria:

• Patients treated with a PCC for an urgent invasive procedure without active hemorrhage

• Patients treated with PCC not taking a VKA

• Unavailable pre- or post-treatment INR lab values

• Pregnant patients