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Antihistamine for Prevention of HTR After Blood Primed CPB

NCT07536152 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

  • Blood Transfusion Associated Adverse Reactions

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

Sponsors & Collaborators

  • Misr University for Science and Technology

    collaborator OTHER

  • Kasr El Aini Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-11-30
Completion
2026-12-31

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07536152 on ClinicalTrials.gov