The Impact of Prothrombin Complex Concentrate Versus Fresh Frozen Plasma for Hemorrhage Management in Cardiac Surgery: A Systematic Review and Meta-analysis of Randomized Clinical Trials

Authors: Grillo, IT; Katsuyama, E; Aguiar, CC; Passos, FS; Costa, BS; Treml, RE; Ehler, J; Kirov, H; Doenst, T; Caldonazo, T

Affiliations: Department of Medicine, University of Buenos Aires, Buenos Aires, Argentina. Department of Medicine, ABC School of Medicine University Center, São Paulo, Brazil. Department of Thoracic Surgery, Mater Dei Hospital, Salvador, Brazil. Department of Medicine, Nove de Julho University, Bauru, Brazil. Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, CA. Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany. Department of Cardiothoracic Surgery, Jena University Hospital, Jena, Germany.

Publication: Journal of Cardiothoracic and Vascular Anesthesia; 2025

ABSTRACT: OBJECTIVE To clarify the efficacy and safety endpoints, comparing prothrombin complex concentrate (PCC) versus fresh frozen plasma (FFP) for hemorrhage management in cardiac surgery. DESIGN Systematic review and meta-analysis of randomized clinical trials (RCTs). SETTING Tertiary care. PARTICIPANTS Adult patients who developed hemorrhage related to coagulation factor deficiency during cardiac surgery. INTERVENTIONS PCC or FFP for hemorrhage management in cardiac surgery. MEASUREMENTS AND MAIN RESULTS A systematic search was conducted in PubMed, Embase, and Cochrane Library and identified RCTs comparing PCC with FFP for hemorrhage management in cardiac surgery. The primary outcome was postintervention hemoglobin levels. Secondary outcomes included 30-day mortality, transfusion requirements, adverse events, postintervention international normalized ratio, and reoperation rates. Categorical values were analyzed using risk ratios with 95% confidence intervals (CIs), whereas continuous values were compared using the mean difference and standardized mean difference with 95% CIs. Statistical analyses were conducted using R software, version 4.4.2. Four RCTs (671 patients) were included, with 343 (51.1%) patients receiving PCC. PCC was associated with higher postintervention hemoglobin levels (mean difference 1.17 g/dL, 95% CI 0.93-1.41, p < 0.01). Compared with FFP, the PCC group required fewer red blood cell transfusions at 24 hours, had reduced use of recombinant factor VII, and demonstrated improved postintervention international normalized ratio. CONCLUSION In patients undergoing cardiac surgery with significant bleeding, PCC was associated with higher postintervention hemoglobin levels and reduced transfusion needs compared with FFP, without an increase in adverse events.