Congenital Heart Surgery in Pediatric Patients With Beta-Thalassemia Major

NCT ID: NCT04367701

Last Updated: 2020-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-15

Study Completion Date

2019-08-30

Brief Summary

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Authors compared incidence of Hemolysis on Cardiopulmonary Bypass surgery for repair of congenital heart disease in Pediatric Patients between patients with thalassemia major and control group

Detailed Description

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Conditions

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Hemolysis

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Thalassemia group

16 pediatric patients with thalassemia major undergoing surgery for repair of congenital heart disease.

Authors measure hemolysis by free plasma hemoglobin concentration.

Hemolysis

Intervention Type DIAGNOSTIC_TEST

Authors measured free plasma hemoglobin concentration in gram

Control group

25 pediatric patients with demographic data related to those in thalassemia group, undergoing surgery for repair of congenital heart disease.

Authors measure hemolysis by free plasma hemoglobin concentration

Hemolysis

Intervention Type DIAGNOSTIC_TEST

Authors measured free plasma hemoglobin concentration in gram

Interventions

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Hemolysis

Authors measured free plasma hemoglobin concentration in gram

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Pediatric Patients with thalassemia major.
* Pediatric Patients with congenital heart disease undergoing surgical repair.

Exclusion Criteria

* known hepatic or renal disease
* uncontrolled active hemolytic reaction
* emergency surgery
* redo surgery
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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simon Halim Armanious

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Galal Mo El kadi, Doctor

Role: STUDY_CHAIR

Professor

Other Identifiers

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Thalassemia CHD

Identifier Type: -

Identifier Source: org_study_id

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