Recombinant Factor VIIa or Four-Factor Prothrombin Complex Concentrate for Cardiac Surgery Bleeding

Introduction: While guidelines suggest either recombinant activated factor VIIa (rFVIIa) or four-factor prothrombin complex concentrate (4F-PCC) may be used for refractory bleeding during cardiac surgeries, their direct comparative efficacy and safety data are limited. This study aims to compare the clinical efficacy and safety of rFVIIa versus 4F-PCC when administered intraoperatively for refractory bleeding in adult cardiac surgery patients.


Methods: This retrospective cohort study included adults undergoing cardiopulmonary bypass (CPB) cardiac surgery at a single tertiary academic center between June 1, 2021 and August 1, 2024 who received either intraoperative rFVIIa or 4F-PCC. The primary outcome was total blood products transfused within 24 hours after drug administration. Secondary outcomes included surgical re-exploration, mechanical ventilation duration, length of stay, 30-day mortality, and safety events. Continuous variables were analyzed using independent t-tests or Mann-Whitney U tests, as appropriate for data distribution. Categorical variables were compared using chi-square or Fischer’s exact tests.


Results: A total of 141 patients (99 rFVIIa, 42 4F-PCC) were included. The patients underwent complex procedures such as redo-sternotomies (38%) and major aortic surgeries (33%). The median initial dose was 22 mcg/kg for rFVIIa and 25 units/kg for 4F-PCC. At 24 hours, the median blood product units transfused were similar (5 units in both groups; P = 0.839). Cumulative total chest tube output was 2792 mL in the rFVIIa group vs. 3139 mL in the 4F-PCC group (P = 0.827). Surgical re-exploration occurred in 28% vs. 19% (P = 0.250). Mechanical ventilation duration was 32.12 hours vs. 49 hours (P = 0.292). Thirty-day mortality was 11.1% vs. 7.1% (P = 0.555). New RRT occurred in 10% vs. 2% (P = 0.174). Costs ($10,891 vs $10,552; P=0.836), transfusion complications (2.0% vs 0%; P=0.999), thrombosis (19.2% vs 14.3%; P=0.485), and myocardial infarction rates (0% vs 2.4%; P=0.298) were similar.


Conclusions: In this cardiac surgery population, rFVIIa and 4F-PCC demonstrated similar efficacy and safety in managing refractory intraoperative bleeding. These findings support guideline and institutional practice flexibility in agent selection and highlight the need for prospective studies to further optimize use.