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NCT04367701 Clinical Trial

Congenital Heart Surgery in Pediatric Patients With Beta-Thalassemia Major

Hemolysis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04367701
Other study ID # Thalassemia CHD
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 15, 2012
Est. completion date August 30, 2019

Study information
Verified date April 2020
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 41
Est. completion date August 30, 2019
Est. primary completion date August 15, 2019
Accepts healthy volunteers
Gender All
Age group 6 Months to 12 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Hemolysis
Authors measured free plasma hemoglobin concentration in gram

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Outcome
Type Measure Description Time frame Safety issue
Primary Hemolysis Authors measure hemolysis by free plasma hemoglobin concentration 3 hours
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