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Recruiting Phase 4 NCT07536152

Antihistamine for Prevention of HTR After Blood Primed CPB

Phase 4 – monitoring after market approval
Conditions: Blood Transfusion Associated Adverse Reactions

Sponsor: Kasr El Aini Hospital

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * Acyanotic congenital heart disease. * Age :1 -7 years. * Genre: both. Exclusion Criteria: * Redo patient. * History of allergy to antihistamines. * Bleeding disorders with INR \> 1.5 and/or platelets \< 50,000. * Emergency procedure.
Interventions
Antihestamine
DRUG
Placebo
DRUG
Locations 1
Egypt (1)
Misr Universty for Scince and Technology
Giza , October
Ahmed Mohamed Elhaddad, Assisstant Professor
Technical details
Status
Recruiting
Phase
Phase 4
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
1 Year
Maximum age
7 Years
Healthy volunteers
No
Start date
01.03.2026
Completion date
01.12.2026
Registry ID
NCT07536152
Source
clinicaltrials.gov
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