NCT07536152

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
7mo left

Started Mar 2026

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Mar 2026Dec 2026

Study Start

First participant enrolled

March 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

April 11, 2026

Last Update Submit

April 16, 2026

Conditions

Blood Transfusion Associated Adverse Reactions

Keywords

prevention of hypotensive transfusion reaction

Outcome Measures

Primary Outcomes (1)

  • hypotention episode incidance

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

    15 min,post cardiopulmonary bypass weaning

Study Arms (2)

Antihistamine

ACTIVE COMPARATOR

chlorpheniramine 0.25 mg/Kg in 2 ml

Drug: Antihestamine

control

PLACEBO COMPARATOR

equal volume of normal saline

Drug: Placebo

Interventions

AntihestamineDRUG

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

Also known as: chlorpheniramine
Antihistamine
PlaceboDRUG

equal volume normal saline

control

Eligibility Criteria

Age1 Year - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Acyanotic congenital heart disease.
  • Age :1 -7 years.
  • Genre: both.

You may not qualify if:

  • Redo patient.
  • History of allergy to antihistamines.
  • Bleeding disorders with INR \> 1.5 and/or platelets \< 50,000.
  • Emergency procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Misr Universty for Scince and Technology

Giza, October, 12582, Egypt

RECRUITING

MeSH Terms

Conditions

Transfusion Reaction

Interventions

Chlorpheniramine

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

PheniraminePyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant professor

Study Record Dates

First Submitted

April 11, 2026

First Posted

April 17, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations

EG(1)