Thrombotic Complications of Low-Dose Versus High-Dose Four-Factor Prothrombin Complex Concentrate for Massive Bleeding in Pediatric Cardiovascular Surgery.

Introduction: Major bleeding is a life-threatening complication in pediatric cardiovascular surgery, particularly in neonates and infants with immature coagulation systems and congenital heart defects (CHD). Cardiopulmonary bypass (CPB) exacerbates these risks by depleting coagulation factors and platelets. Four-factor prothrombin complex concentrates (4F-PCC) provide targeted hemostatic correction but carry potential thrombotic risks.

Methods: Among 1296 pediatric patients who underwent cardiovascular surgery between January 2018 and April 2024, a retrospective cohort study analyzed 104 patients who received 4F-PCC. Patients were grouped into low-dose (< 35 U/kg) and high-dose (≥ 35 U/kg). Thrombotic complications were evaluated within 15 days after use.

Results: The median age was 1 month (IQR: 0-7.5), and 69.23% of patients were male. Common diagnoses included hypoplastic left heart syndrome (14.42%), ventricular septal defect (13.46%), and coarctation of the aorta (12.5%). Frequent procedures included Norwood procedure (14.42%) and ventricular septal defect closure (13.46%). Thrombotic complications occurred in 6.73% overall, with no significant differences between high-dose (5.26%) and low-dose (8.51%) groups (p = 0.698). High-dose 4F-PCC was associated with shorter CPB times (p = 0.007) (Cohen's d 0.537) but higher reintervention rates (57.89% vs. 34.04%; p = 0.015) (Cramér's V 0.118).

Conclusion: High-dose 4F-PCC was not associated with increased thrombotic complications. Thrombotic complications in this study were inferior to all-cause thrombotic complications in pediatric cardiovascular surgery of 11%. These findings support 4F-PCC as a viable option for managing severe bleeding in pediatric cardiovascular surgery. Further studies should explore dose optimization and preventive applications.