Congenital Heart Surgery in Pediatric Patients With Beta-Thalassemia Major

Congenital Heart Surgery in Pediatric Patients With Beta-Thalassemia Major : Analysis of Hemolysis During Cardiopulmonary Bypass

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

Study Overview

• Status: Completed
• Conditions: Hemolysis
• Intervention / Treatment: Diagnostic test: Hemolysis

• Study Type: Observational
• Enrollment (Actual): 41

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 12 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with thalassemia major undergoing surgical repair for congenital heart disease

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Thalassemia group; 16 pediatric patients with thalassemia major undergoing surgery for repair of congenital heart disease. Authors measure hemolysis by free plasma hemoglobin concentration.	Diagnostic test: Hemolysis; 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	Diagnostic test: Hemolysis; Authors measured free plasma hemoglobin concentration in gram

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemolysis	Authors measure hemolysis by free plasma hemoglobin concentration	3 hours

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: Galal Mo El kadi, Doctor, Professor

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2012
• Primary Completion (Actual): August 15, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Thalassemia; beta-Thalassemia; Hemolysis
• Other Study ID Numbers: Thalassemia CHD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes