NCT07536152

Antihistamine for Prevention of HTR After Blood Primed CPB

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Kasr El Aini Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 7 Years
• Healthy volunteers: Not accepted

Summary

This study was a randomized, double-blinded, placebo-controlled study, will be conducted at a university hospital. Forty children undergoing elective repair of congenital heart defect will be included. The patients will randomly allocated (20 patients in each group) to receive a single dose of combined chlorpheniramine or normal saline intravenously immediately after separation from CPB prior to protamine administration.

Conditions

• Blood Transfusion Associated Adverse Reactions

Interventions

Type	Name	Description
DRUG	Antihestamine	chlorpheniramine 0.25 mg/Kg in 2 ml after protamine
DRUG	Placebo	equal volume normal saline

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: Egypt