Evaluation of Four-Factor Prothrombin Complex Concentrate Dosing for Major Bleeding Following Cardiac Surgery

Four-factor prothrombin concentrate complex (4F-PCC) may be used for significant bleeding following cardiac surgery but the optimal dosing has not been established. The purpose of this study was to compare two dosing strategies of 4F-PCC in cardiac surgery patients. This retrospective chart review evaluated 4F-PCC dosing of 25 units/kg compared to 12.5 units/kg in cardiac surgery patients following a protocol change for 4F-PCC dosing. The primary outcome was major bleeding, defined as the number of patients receiving ≥3 packed red blood cell (PRBC) transfusions within 24 h of 4F-PCC administration. Secondary outcomes included other surrogate markers for bleeding (eg, Use of other blood products and hemostatic agents), thrombotic events within 14 days of surgery, hospital length of stay, and all-cause mortality. A total of 42 patients were included (31 patients in the 25 units/kg group and 11 patients in the 12.5 units/kg group). There was no difference in the number of patients that received ≥3 PRBC transfusions between the two groups with 15 patients (47.4%) in 25 units/kg group and 3 patients (27.3%) in 12.5 units/kg (P = .299). Additionally, no difference was observed in amount of additional hemostatic agents administered, hospital length of stay or mortality between the two groups. A higher rate of thromboembolic events was observed among patients receiving 25 units/kg vs 12.5 units/kg (22.6% vs 0%, P = .161). Reduced dosing of 4F-PCC from 25 units/kg to 12.5 units/kg following cardiac surgery resulted in no difference in clinical or effectiveness outcomes.