At a glance
ClinicalIndex Comparison Record- ✓Chronic anticoagulation with warfarin
- ✓Initial INR ≥2
- ✓Emergent bleeding such as intracranial hemorrhage, gastrointestinal hemorrhage, or urgent invasive procedures
- ✓Urgent surgery requiring reversal of INR to ≤1.5
- ✕Age younger than 18 years
- ✕History of heparin-induced thrombocytopenia (HIT)
- ✕No initial or post-administration INR readings available
- ✕Initial INR <2
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized Study of Fixed Versus Variable Dosing of 4-factor Prothrombin Complex Concentrate for Emergent Warfarin Reversal at a Large Tertiary Care Medical Center
In Brief
A Phase 4 clinical trial evaluating 4-factor prothrombin complex concentrate (4FPCC) for Acute Bleeding on Long-Term Anticoagulation Therapy and 3 related conditions. Completed, enrolled 79 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
4-factor prothrombin complex concentrate (4FPCC) contains all of the vitamin K-dependent clotting factors inhibited by warfarin, making it desirable for use in warfarin reversal for emergent bleeds. Multiple guidelines currently recommend 4FPCC for warfarin reversal in vitamin K-dependent major bleeding or intracranial hemorrhage. 4FPCC has a fast onset of action and has demonstrated significant reversal of INR within 10 minutes. Its duration of action is up to 8 hours, and for this reason it should be given concurrently with vitamin K. Vitamin K has a delayed onset of action due to its need to stimulate the synthesis of clotting factors so its effects begin as the effects of 4FPCC diminish. 4FPCC is the standard of care treatment for this clinical population in the Regions Hospital Emergency Department.