Efficacy and Safety of Intraoperative Intravenous Tranexamic- acid in Neonates and Infants Weighing Less Than 5 kg Undergoing Congenital Cardiac Surgery: an Exploratory Retrospective Cohort Study

Abstract

Background: Pediatric congenital heart diseases are associated with coagulation abnormalities, which are aggravated during cardiopulmonary bypass (CPB). There still have scarce information about the safety and efficacy of tranexamic acid (TXA) in neonates and infants’ weight < 5 kg. Objective: To determine the efficacy of intravenous TXA in neonates and infants’ weight < 5 kg undergoing congenital cardiac surgery about postoperative blood loss, intra- and 24 hours postoperative transfusion, and postoperative morbidity/mortality. Material and methods: A retrospective study was conducted between January 2015 and December 2021 in neonates and infants’ weight < 5 kg undergoing congenital cardiac surgery under CPB. Patients with history of seizure, stroke, preoperative acute kidney injury, bleeding disorder, and who received TXA in the ICU were excluded. Patients were divided into the controlled group (n=19) and the TXA group (n=103). Results: TXA group had significant lower postoperative blood loss at 12 hours but not 24 hours postoperative allogeneic transfusion. Single bolus TXA > 30 mg/kg before incision tended to decrease postoperative bleeding at 12 hours (b = -0.264; P=0.079). High dose TXA > 50 mg/kg didn’t increase the efficacy of TXA. TXA 60 and 82 mg/kg were associated with postoperative seizure and arterial thrombosis. Conclusion: Intravenous TXA showed efficacy in decreasing postoperative blood loss at 12 hours but not 24 hours postoperative allogeneic transfusion. A high dose (> 50 mg/kg) of TXA did not increase its efficacy. The postoperative seizure was associated with high dose TXA. An optimal dose of TXA is warranted for further study.