Fixed Versus Variable Dosing of 4-factor Prothrombin Complex Concentrate for Emergent Warfarin Reversal
Status:
Completed
Trial end date:
2019-04-24
Target enrollment:
Participant gender:
Summary
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. 4FPCC is used to reverse
the effects of warfarin when a patient has emergent bleeding. The investigators hope that
this study will help doctors treat patients quicker in the future. In addition, it may be
cheaper for patients and hospitals. This is the same medication the doctor would use to
reverse warfarin's effects, but at a lower dose.
Hypothesis: A fixed dose of 4FPCC will be comparable to FDA-approved variable dosing for
reversal of warfarin-induced anticoagulation (defined as an international normalized ratio
[INR] ≤ 1.5) in patients with an INR ≥2 experiencing an emergent bleed or requiring emergent
surgery.