Comparative efficacy and safety of prothrombin complex concentrate versus fresh frozen plasma in cardiac surgery: A meta-analysis of randomized controlled trials

Abstract

Background

Postoperative bleeding due to acquired coagulopathy is a common and serious complication following cardiac surgery. Fresh frozen plasma (FFP) and prothrombin complex concentrate (PCC) are the principal therapies used to correct coagulopathy in this setting. However, their comparative effectiveness and safety remain uncertain.

Methods

MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were systematically searched through March 2025 to identify randomized controlled trials (RCTs) comparing PCC and FFP in adult cardiac surgery patients with postoperative coagulopathy. All analyses were performed using Review Manager (Version 5.4; Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2020).

Results

Four RCTs including a total of 671 patients were eligible for inclusion. Compared to FFP, PCC was associated with significantly lower chest tube drainage volume (mean difference [MD], −162.14; 95% CI: −264.47 to −59.81 mL; P = 0.002; I² = 49%), reduced RBC transfusion rate (risk ratio [RR], 0.77; 95% CI: 0.65 to 0.91; P = 0.002; I² = 27%), and fewer mean RBC units administered (MD, −0.86 units; 95% CI: −1.23 to −0.49 units; P < 0.001; I² = 0%). No significant differences were found between groups in the rates of reoperation for bleeding, thromboembolic events, stroke or transient ischemic attack, acute kidney injury, or mortality. Length of stay in the intensive care unit and hospital were also comparable between groups.

Conclusion

PCC demonstrates superior hemostatic efficacy compared to FFP in adult cardiac surgery patients, while maintaining a comparable safety profile. These findings support its use as a more effective and practical alternative for managing postoperative coagulopathy in this population.