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.

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.