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Recruiting NCT07536152

Antihistamine for Prevention of HTR After Blood Primed CPB

Phase IV Interventional Blood Transfusion Associated Adverse Reactions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Antihestamine, Placebo.
Who it may be relevant to
Registry conditions: Blood Transfusion Associated Adverse Reactions. Basic parameters: 1 year — 7 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

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

Primary outcome measures

  • hypotention episode incidance [Time frame: 15 min,post cardiopulmonary bypass weaning]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Misr Universty for Scince and Technology — Giza

Identifiers

NCT: NCT07536152 · 2026/0002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗