Caroline Kruszecki, PharmD
PGY2 Critical Care Pharmacy Practice Resident
n/a
Milwaukee, Wisconsin
Disclosure information not submitted.
Danielle Mabrey, PharmD, BCCCP
Critical Care Pharmacist
Froedtert Hospital, United States
Disclosure information not submitted.
Kim Haldeman, PharmD, BCCCP
Critical Care Pharmacist
Froedtert Hospital, United States
Disclosure information not submitted.
Lindsey Dailey, PharmD
Critical Care Pharmacist
Froedtert Hospital, United States
Disclosure information not submitted.
Elizabeth Scanlon, PharmD, BCCCP
Critical Care Pharmacist
Froedtert and the Medical College of Wisconsin Froedtert Hospital, United States
Disclosure information not submitted.
Title: Fixed Dose Prothrombin Complex Concentrate in Vitamin K Antagonist-Related Intracerebral Hemorrhage
Introduction: A component of vitamin k antagonist (VKA) reversal in the setting of intracranial hemorrhage (ICH) includes four-factor inactivated prothrombin complex concentrate (4F-PCC). New literature suggests a fixed-dosing (1500 units) strategy may be an alternative to traditional weight-based dosing, however evidence for use in patients with ICH is sparse. The goal of this study was to evaluate the rate of successful warfarin reversal, defined as an international normalized ratio (INR) < 1.5, and identify risk factors for reversal failure when using fixed-dose 4F-PCC in patients with an ICH.
Methods: This was a retrospective cohort study of patients admitted to the Neurology Intensive Care Unit between October 17, 2018 and March 31, 2021 with a documented ICH on warfarin and who received at least one dose of fixed-dose 4F-PCC. Results were generated using descriptive statistics, Fisher’s Exact test for comparison of categorical variables, and logistic regression analysis to identify risk factors for inadequate reversal.
Results: Eighty-two patients were included. The patient cohort was primarily male (56%), an average of 75.6 ± 16.4 years old, presented with a traumatic ICH (59.8%), had an average INR of 3.7 ± 2.5 and a Glasgow Coma Scale score of 12.4 ± 4.1 (when reported). Fifty-nine patients (72%) achieved a post-4F-PCC INR of < 1.5. Logistic regression analysis identified higher presenting INR as a risk factor for inadequate INR reversal (OR 2.029, 95% CI (1.343, 3.065)) and longer time to repeat INR as a protective factor (OR 0.989, 95% CI (0.981, 0.998). Bleed type and BMI were not found to be statistically significant.
Conclusions: Most patients achieved goal INR reversal with a 1500 unit fixed-dose regimen of 4F-PCC. High presenting INR was a significant risk factor for reversal failure, which is consistent with previous studies, suggesting these patients may need a larger 4F-PCC dose. Previous studies have identified elevated BMI as a risk factor for reversal failure, which was not observed in this study. Fixed-dose 4F-PCC appears to be a reasonable dosing strategy for warfarin reversal in some patients presenting with ICH, however further prospective studies are needed to concretely define risk factors for inadequate reversal and optimal dosing strategies.