Tranexamic acid use in neonates and children: a narrative review of current evidence, and knowledge gaps

Abstract Background: Neonatal anaemia is common, particularly in preterm and critically ill infants, and is frequently managed with red blood cell transfusion despite well-recognised associated morbidity. Patient blood management strategies aim to reduce transfusion exposure, and tranexamic acid (TXA) has emerged as a potential pharmacological adjunct. However, evidence supporting the use of TXA in neonates remains limited. Methods: We conducted a comprehensive narrative review of peer-reviewed literature published between January 2015 and December 2025. Searches were performed in PubMed/MEDLINE, Scopus, and Web of Science using Medical Subject Headings and keyword combinations related to neonates, children, blood conservation strategies, and TXA. Eligible studies included systematic reviews, randomised controlled trials, observational cohort studies, and case reports evaluating TXA use in paediatric and neonatal populations across surgical, critical care, and selected medical contexts. Adult-only and animal studies were excluded. Findings were synthesised qualitatively. Results: Seventeen studies met the inclusion criteria. Evidence consistently supports the use of TXA as part of multimodal blood-conservation strategies in elective paediatric surgery with predictable bleeding, particularly in craniosynostosis surgery, where reductions in blood loss and transfusion requirements were observed. In paediatric cardiac surgery and life-threatening haemorrhage, TXA may reduce bleeding and early mortality; however, benefits were less consistent in neonates. Evidence for TXA use in neonatal medical indications was sparse and inconclusive. Safety data suggest a dose- and context-dependent risk of seizures, with limited neonatal-specific adverse event reporting. Conclusion: TXA shows promise as a pharmacological blood conservation strategy in selected paediatric surgical populations, but evidence supporting its routine use in neonates remains limited. The unique haemostatic physiology, immature renal clearance, and neurological vulnerability of neonates necessitate cautious use. High-quality neonatal pharmacokinetic studies and prospective trials are urgently needed to define optimal dosing, safety, and efficacy before widespread adoption in neonatal practice.