Comparison of Hemostatic Outcomes in Patients Receiving Fixed-Dose vs. Weight-Based 4-Factor Prothrombin Complex Concentrate.

Background: Four-factor prothrombin complex concentrate (4F-PCC) is a blood coagulation product indicated for urgent reversal of warfarin. Currently there are no studies using 4F-PCC as a fixed dose to achieve hemostasis with warfarin as well as direct factor Xa inhibitors.

Objectives: The objective of this study was to evaluate the efficacy and safety of 4F-PCC administration using a fixed dose of approximately 2000 factor IX units to achieve hemostasis in anticoagulated patients, compared with weight-based therapy.

Methods: This single-center, retrospective cohort study was performed at a 433-bed tertiary care hospital in central Kentucky. Patients from January 1, 2014 to December 31, 2018 were included if they were 18 years or older and received 4F-PCC for hemostasis of oral anticoagulation. Efficacy was assessed by determining if clinically effective hemostasis was achieved after receiving a fixed-dose vs. a weight-based dose of 4F-PCC.

Results: Seventy-two patients were included in the study. Thirty-eight received weight-based dosing, compared with 34 receiving a fixed dose. Results yielded no statistical difference in clinically effective hemostasis using a fixed-dose vs. weight-based dosing, 91.2% and 78.9%, respectively (p = 0.150). There was no significant difference in adverse events, length of stay, or in-hospital mortality between groups; however, significant acquisition cost savings was realized.

Conclusions: A fixed-dose regimen of approximately 2000 factor IX units of 4F-PCC may be a reasonable approach to achieve hemostasis in patients receiving warfarin or factor Xa inhibitors. Additionally, utilization of a fixed-dose regimen may lead to significant acquisition cost savings for facilities.