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NCT Number: NCT07536152

Antihistamine for Prevention of HTR After Blood Primed CPB

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.

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Key information

Conditions

Blood Transfusion Associated Adverse Reactions Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Transfusion Reaction

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Misr Universty for Scince and Technology

Giza, October, 12582, Egypt

Location status: Recruiting

Location contact

Ahmed Mohamed Elhaddad, Assisstant Professor

CONTACT

[email protected]

0201224042847

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Antihestamine

Drug

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

Other names: chlorpheniramine

Placebo

Drug

equal volume normal saline

Primary outcomes

  1. hypotention episode incidance

    Time frame: 15 min,post cardiopulmonary bypass weaning

    Incidence of hypotension (20% MBP drop < baseline)15 minutes post-CBP weaning

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Collaborators

  • Misr University for Science and Technology

Registry information

Official study title

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

Acronym: HTR - CPB

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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