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Iron Overload Assesment in Sickle Cell Anemia and Sickle Cell Thalassemia

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: NCT00512226
Recruitment Status : Completed
First Posted : August 7, 2007
Last Update Posted : August 26, 2011
Sponsor:
Collaborator:
Wolfson Medical Center
Information provided by (Responsible Party):
Dr Koren Ariel, HaEmek Medical Center, Israel

Study Description
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Brief Summary:
Iron overload is well study in Thalassemia patients and it's not only related to blood transfusions, since intestinal iron absorption is also increased in those patients. Sickle cell patients didn't develope significant clinical symptoms and signs of iron overload in spite frequent transfusions. The purpouse of this study is to assess the iron overload in Sickle cell anemia and Sickle cell Thalassemia patients using clinical parameters and cardiac T2*MRI in order to determine the cardiac and liver iron.

Condition or disease Intervention/treatment Phase
Sickle Cell Anemia Sickle Cell Thalassemia Iron Overload MRI Other: Cardiac and Liver T2* MRI Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical and Laboratory Assessment of Iron Overload in Sickle Cell Anemia and Sickle Cell Thalassemia Using T2* Cardiac MRI.
Study Start Date : September 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Other: Cardiac and Liver T2* MRI
    Laboratory examinations that are routinely used in follow up of those patients and T2* MRI analysis.

Outcome Measures
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Primary Outcome Measures :
  1. Assessment of Iron overload. [ Time Frame: December 2008 ]

Secondary Outcome Measures :
  1. Institute the criteria for iron chelator treatment [ Time Frame: December 2008 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All the patients with Sickle cell anemia and Sickle cell Thalasemia that are currently in follow up at the Pediatric Hematology Unit

Exclusion Criteria:

  • Age below 18 years.
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): NCT00512226


Locations
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Israel
Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
Wolfson Medical Center
Investigators
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Principal Investigator: Ariel Koren, MD Pediatric Hematology Unit, Ha'Emek Medical Center
More Information
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Responsible Party: Dr Koren Ariel, Head of Pediatric Hematology Unit and Pediatric Dpt B, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00512226    
Other Study ID Numbers: 0037-07-EMC
First Posted: August 7, 2007    Key Record Dates
Last Update Posted: August 26, 2011
Last Verified: August 2011
Keywords provided by Dr Koren Ariel, HaEmek Medical Center, Israel:
Sickle Cell Anemia
Sickle Cell Thalassemia
Iron Overload
MRI
Additional relevant MeSH terms:
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Anemia
Thalassemia
Anemia, Sickle Cell
Iron Overload
Hematologic Diseases
Anemia, Hemolytic, Congenital
 Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases