Phase 4 Antihistamine Trial for HTR Prevention in 40 Children, NCT07536152

NIH registered a new Phase 4 clinical trial (NCT07536152) on ClinicalTrials.gov studying antihistamine (chlorpheniramine) for prevention of blood transfusion-associated adverse reactions in 40 pediatric patients undergoing congenital heart defect repair with blood-primed cardiopulmonary bypass. The randomized, double-blinded, placebo-controlled study will administer a single intravenous dose of chlorpheniramine or normal saline immediately after bypass separation.

Healthcare providers and clinical investigators involved in pediatric cardiac surgery and transfusion medicine should note this post-marketing surveillance trial, which may contribute to evidence regarding antihistamine efficacy in reducing transfusion reactions in vulnerable pediatric populations undergoing complex cardiac procedures.