Actively Recruiting

Phase 4
Age: 1Year - 7Years
All Genders
NCT07536152

Antihistamine for Prevention of HTR After Blood Primed CPB

Led by Kasr El Aini Hospital · Updated on 2026-04-21

40

Participants Needed

1

Research Sites

39 weeks

Total Duration

On this page

Sponsors

K

Kasr El Aini Hospital

Lead Sponsor

M

Misr University for Science and Technology

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Antihistamine for Prevention of HTR After Blood Primed CPB

Who Can Participate

Age: 1Year - 7Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Acyanotic congenital heart disease
  • Age between 1 and 7 years
  • Both genders included
Not Eligible

You will not qualify if you...

  • Previous heart surgery (redo patient)
  • Allergy to antihistamines
  • Bleeding disorders with INR greater than 1.5 and/or platelets less than 50,000
  • Emergency procedure

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Misr Universty for Scince and Technology

Giza, October, Egypt, 12582

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Antihistamine for Prevention of HTR After Blood Primed CPB | DecenTrialz