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RECRUITING
NCT07536152
PHASE4

Antihistamine for Prevention of HTR After Blood Primed CPB

Sponsor: Kasr El Aini Hospital

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

1 Year - 7 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-03-01

Completion Date

2026-12

Last Updated

2026-04-21

Healthy Volunteers

No

Interventions

DRUG

Antihestamine

chlorpheniramine 0.25 mg/Kg in 2 ml immediately after separation from CPB, before protamine administration

DRUG

Placebo

equal volume normal saline

Locations (1)

Misr Universty for Scince and Technology

Giza, October, Egypt