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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00512226
Other study ID # 0037-07-EMC
Secondary ID
Status Completed
Phase N/A
First received August 5, 2007
Last updated August 25, 2011
Start date September 2007
Est. completion date December 2010

Study information

Verified date August 2011
Source HaEmek Medical Center, Israel
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

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

Locations

Country Name City State
Israel Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center Afula

Sponsors (2)

Lead Sponsor Collaborator
HaEmek Medical Center, Israel Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of Iron overload. December 2008 No
Secondary Institute the criteria for iron chelator treatment December 2008 No
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