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Congenital Heart Surgery in Pediatric Patients With Beta-Thalassemia Major

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04367701
Recruitment Status : Completed
First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
simon Halim Armanious, Ain Shams University

Study Description
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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

Condition or disease Intervention/treatment
Hemolysis Diagnostic Test: Hemolysis

Study Design
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Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Case-Crossover
Time Perspective: Retrospective
Official Title: Congenital Heart Surgery in Pediatric Patients With Beta-Thalassemia Major : Analysis of Hemolysis During Cardiopulmonary Bypass
Actual Study Start Date : January 15, 2012
Actual Primary Completion Date : August 15, 2019
Actual Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Hemolysis [ Time Frame: 3 hours ]
    Authors measure hemolysis by free plasma hemoglobin concentration


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients with thalassemia major undergoing surgical repair for congenital heart disease
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04367701


Sponsors and Collaborators
Ain Shams University
Investigators
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Study Chair: Galal Mo El kadi, Doctor Professor
More Information
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Responsible Party: simon Halim Armanious, Lecturer, Ain Shams University
ClinicalTrials.gov Identifier: NCT04367701    
Other Study ID Numbers: Thalassemia CHD
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Hemolysis
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Pathologic Processes