Prophylactic Antihistamine for Prevention of Hypotensive Transfusion Reaction After Blood Primed Cardiopulmonary Bypass in Pediatric Cardiac Surgery: a Randomized-controlled Study

What this Trial Is About

Researchers are studying children with acyanotic congenital heart disease undergoing elective repair of a congenital heart defect to evaluate the use of an antihistamine for preventing hypotensive transfusion reactions after blood-primed cardiopulmonary bypass (CPB). This randomized, double-blinded, placebo-controlled Phase 4 study aims to compare the effects of combined chlorpheniramine versus a placebo in this pediatric population. Participants will be randomly assigned to one of two groups: one group will receive a single intravenous dose of chlorpheniramine at 0.25 mg/kg in 2 ml, and the other group will receive an equal volume of normal saline as a placebo. This dose is administered immediately after separation from CPB and before protamine administration. The study includes 40 children aged 1 to 7 years. During the study, researchers will monitor for episodes of hypotension within 15 minutes after weaning from cardiopulmonary bypass. Children will be closely observed during the procedure, and their response to the treatment will be assessed. The study will continue until December 2026, with safety and outcome measures collected during and after the procedure to evaluate the incidence of hypotensive transfusion reactions.

Antihistamine for Prevention of HTR After Blood Primed CPB