Abstract

Introduction: Anticoagulation with warfarin is associated with numerous adverse events and complications, the most significant being intracranial hemorrhage (ICH). Prothrombin complex concentrate (PCC) is recommended for international normalization ratio (INR) reversal, however data regarding its use following ICH is variable with regards to dosing, infusion rate, and product choice. Available evidence supports efficacy of 4-factor PCC when compared to fresh frozen plasma (FFP), yet there are no direct comparisons with 3-factor products. Methods: We conducted a retrospective chart review of all patients receiving 3-factor PCC for reversal of INR following ICH between the dates of January 1, 2012 and August 1, 2013. Patients were excluded if they received PCC for an alternate indication or did not have an available baseline and/or repeat INR following PCC administration. Results: A total of 36 patients were included, one half of which were female. On presentation, the median age was 69 years and the mean INR was 4.1 ± 1.0. Thirty-three of 36 patients (91.7%) achieved an initial goal INR (≤ 1.4) following a single PCC dose, with the mean INR after PCC infusion being 1.2 ± 0.2. The average dose of PCC given after rounding to the nearest vial size was 31 IU/kg. Median time from PCC infusion to INR was 49 minutes. Vitamin K was utilized in 34 (94.4%) patients while FFP was given to only 5 (13.9%). In those with a baseline INR greater than 4.5, there was no difference in the probability of INR reversal, with 8 of 9 patients reaching goal INR after a single dose per our protocol (p<0.99). No patient experienced a documented thrombotic event within 7 days of PCC administration. PCC was infused over a median duration of 14 minutes (198 IU/minute) without any documented infusion reactions. Conclusions: Implementation of a fixed weight-based dosing protocol for 3-factor PCC was effective at providing rapid and complete INR reversal without any adverse events. With the new FDA approval of 4-factor PCC, 3-factor PCC may offer significant cost savings with similar efficacy however direct comparisons are needed.

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