Congenital Heart Surgery in Pediatric Patients With Beta-Thalassemia Major

Completed

• Conditions: Hemolysis
• Interventions: Diagnostic Test: Hemolysis

• Registration Number: NCT04367701
• Lead Sponsor: Ain Shams University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2012-01-15
• Primary Completion: 2019-08-15
• Study Completion: 2019-08-30
• Status Verified: 2020-04
• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-27
• Last Update Submitted: 2020-04-27
• Study First Posted: 2020-04-29
• Last Update Posted: 2020-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

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

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Exclusion Criteria

• known hepatic or renal disease
• uncontrolled active hemolytic reaction
• emergency surgery
• redo surgery

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Thalassemia group	Hemolysis	16 pediatric patients with thalassemia major undergoing surgery for repair of congenital heart disease. Authors measure hemolysis by free plasma hemoglobin concentration.
Control group	Hemolysis	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

Primary Outcome Measures

Name	Time	Method
Hemolysis	3 hours	Authors measure hemolysis by free plasma hemoglobin concentration