Fixed Versus Variable Dosing of 4-factor Prothrombin Complex Concentrate for Emergent Warfarin Reversal (kcentra)
Acute Bleeding on Long-Term Anticoagulation Therapy, Hemorrhage, Significant Bleeding in Patients With a Coagulopathy (Prolonged Thrombin Time)

About this trial
This is an interventional treatment trial for Acute Bleeding on Long-Term Anticoagulation Therapy
Eligibility Criteria
Inclusion Criteria:
- Chronic anticoagulation with warfarin and initial INR ≥2
- Emergent bleeding (i.e. intracranial hemorrhage, gastrointestinal hemorrhage, urgent invasive procedures, etc.) or urgent surgery requiring reversal of INR to ≤1.5
Exclusion Criteria:
- Younger than 18 years of age
- History of heparin-induced thrombocytopenia (HIT)
- Patients without initial or post-administration INR readings
- Patients with an initial INR <2
- Pregnant patients
- Prisoners
Sites / Locations
- Regions Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Fixed dose 4FPCC
Variable dose 4FPCC
Incorporating a fixed dose of 1500 IU. If the patient receiving the 1500 IU fixed dose remains in a bleeding state and the INR remains above goal, an additional 500 IU may be administered at the physician's discretion to minimize bleeding and attempt to achieve hemostasis.
The FDA-approved variable dosing algorithm is as follows: initial INR 2-3.9: 25 IU/kg (maximum dose 2500 IU), initial INR 4-6: 35 IU/kg (maximum dose 3500 IU), and initial INR >6: 50 IU/kg (maximum dose 5000 IU). The patient weight will be obtained using a scale and documented by the treating registered nurse