Antihistamine for Prevention of HTR After Blood Primed CPB

Phase 4RecruitingNCT07536152

Kasr El Aini Hospital40 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Blood Transfusion Associated Adverse Reactions

Interventions

AntihestamineDRUG

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

PlaceboDRUG

equal volume normal saline

Eligibility

Sex: ALLMin age: 1 YearMax age: 7 Years

Medical Language ↔ Plain English

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.

Locations (1)

Misr Universty for Scince and Technology

Giza, October, Egypt

RECRUITING

Outcomes

Primary Outcomes

hypotention episode incidance

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

Time frame: 15 min,post cardiopulmonary bypass weaning

Data from ClinicalTrials.gov

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