Optimization of Anticoagulation Strategy During Cardiopulmonary Bypass in Neonates with Congenital Heart Disease: A Randomized Controlled Trial

Purpose

Neonatal hemostatic immaturity complicates anticoagulation during cardiopulmonary bypass (CPB). Current practice largely follows the strategy of 400 U/kg from adult protocols, as neonatal-specific guidelines and high-quality evidence remain lacking, which frequently fails to achieve adequate anticoagulation. This single-center randomized controlled trial evaluated the initial heparin dose of 600 U/kg to refine neonatal CPB anticoagulation. Patients and Methods: In this prospective, randomized, controlled, single-blind trial, 76 neonates undergoing CPB were assigned to receive an initial heparin dose of either 600 U/kg (n = 38) or 400 U/kg (n = 38). The primary endpoint was the pre- to post-CPB change in prothrombin fragment 1+2 (ΔF1+2). Secondary endpoints included the proportion of neonates achieving the ACT threshold after the initial heparin bolus, perioperative coagulation measures, postoperative blood loss, transfusion requirements, and adverse clinical outcomes.