Kristen Haeger-Overstreet, PharmD,
PGY2 Critical Care Pharmacy Practice Resident
University of Kansas Health System
Kansas City
Disclosure information not submitted.
Lucy Stun, PharmD, BCCCP, DPLA
Pharmacy Clinical Coordinator-Critical Care and Emergency Department
The University of Kansas Health System, United States
Disclosure information not submitted.
Adam Blevins, PharmD, BCCCP
Clinical Pharmacist
The University of Kansas Health System, United States
Disclosure information not submitted.
Brittanie Wieland, PharmD
Clinical Pharmacist
The University of Kansas Health System, United States
Disclosure information not submitted.
Title: Implementation and Evaluation of Fixed Dosing Prothrombin Complex Concentrate for Warfarin Reversal
Introduction: Kcentra™ is a 4-factor prothrombin complex concentrate (4f-PCC) containing exogenous clotting factors II, VII, IX, and X, sourced from human plasma. Based on recommendations made by the American College of Cardiology in 2020, The University of Kansas Health System implemented a fixed dosing protocol for Kcentra™ in the setting of warfarin reversal in August 2020. Our protocol now recommends 1500 units for intracranial hemorrhage, and 1000 units for all other bleeds, in conjunction with vitamin K. Providers have the option to give an additional 500 units based on pre-treatment INR, weight, presence of continued bleeding, and if the INR remains above goal post-treatment.
Methods: A retrospective chart-review was used to evaluate the efficacy of this fixed dose protocol. Patients 18 years and older were included if they received Kcentra™ for reversal of warfarin. Patients were excluded if they were < 18 years old, had a pre-treatment INR of < 2, received a dose lower than recommended, or received Kcentra™ for direct oral anticoagulation (DOAC) reversal or factor deficiency. The primary outcome included achievement of an INR < 2, and secondary outcomes included percentage of patients receiving supplemental doses in addition to the initial bolus, percentage of patients receiving concurrent vitamin K therapy, 30 day mortality, and predicted number of 4f-PCC units conserved.
Results: Twelve patients were included in five months of post-implementation data. The majority of indications included intracranial hemorrhage (41.7%, n=5), followed by reversal for emergent procedure (33.3%, n=4). Four of the twelve patients failed to achieve an INR < 2; one of which received a supplemental dose. Notably, two of the four patients that failed to reverse their INR weighed more than 100kg. All patients received concomitant vitamin K therapy, and one patient died within 30 days of receiving Kcentra™. The predicted number of units conserved was estimated to be 22,900 units.
Conclusions: Overall, this fixed dose 4f-PCC protocol has proven to be effective 67% of the time in terms of INR reversal. Additional data is needed specifically in the obese patients to determine the most appropriate dose for this population. Limitations include lack of standardized INR draws after administration and very small sample size.