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Iron Overload Assesment in Sickle Cell Anemia and Sickle Cell Thalassemia

This study has been completed.
Sponsor:
Collaborator:
Wolfson Medical Center
Information provided by (Responsible Party):
Dr Koren Ariel, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00512226
First received: August 5, 2007
Last updated: August 25, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention
Sickle Cell Anemia
Sickle Cell Thalassemia
Iron Overload
MRI
 Other: Cardiac and Liver T2* MRI

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Assessment of Iron overload. [ Time Frame: December 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Institute the criteria for iron chelator treatment [ Time Frame: December 2008 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Cardiac and Liver T2* MRI
    Laboratory examinations that are routinely used in follow up of those patients and T2* MRI analysis.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00512226

Locations
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
Principal Investigator: Ariel Koren, MD Pediatric Hematology Unit, Ha'Emek Medical Center
  More Information

No publications provided

Responsible Party: Dr Koren Ariel, Head of Pediatric Hematology Unit and Pediatric Dpt B, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00512226     History of Changes
Other Study ID Numbers: 0037-07-EMC
Study First Received: August 5, 2007
Last Updated: August 25, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:
Sickle Cell Anemia
Sickle Cell Thalassemia
Iron Overload
MRI

Additional relevant MeSH terms:
Anemia
Anemia, Sickle Cell
Thalassemia
Iron Overload
Hematologic Diseases
Anemia, Hemolytic, Congenital
 Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 21, 2013