Comparing Prothrombin Complex Concentrate and Fresh Frozen Plasma for Bleeding Control in Cardiac Surgery Using Viscoelastic Testing

What this Trial Is About

This trial evaluates the time required to complete hemostasis treatment when using fresh frozen plasma FFP versus prothrombin complex concentrate PCC in managing bleeding during cardiac surgery. The study focuses on patients undergoing cardiac valve surgery and aims to compare these two treatments using goal-directed bleeding management based on viscoelastic testing. Participants receive either fresh frozen plasma transfusion at 10-15 mlkg or prothrombin complex concentrate at 10-15 IUkg. Treatment decisions are guided by the Rotational thromboelastometry ROTEM test, specifically based on CT-EXTEM prolongation. The study is randomized and double-blinded, comparing these two biological interventions in parallel groups. During the trial, participants will be closely monitored for treatment time, blood product usage, ROTEM parameter changes, and postoperative bleeding over 24 hours. Researchers will measure primary outcomes such as treatment completion time and secondary outcomes including red blood cell and platelet amounts, coagulation test changes, and success of initial coagulation management. The study lasts until October 2026, with follow-up assessments focusing on bleeding control and treatment effectiveness.

Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Cardiac Surgery