Iron Overload Assesment in Sickle Cell Anemia and Sickle Cell Thalassemia

Sickle Cell Anemia Clinical Trial

Official title:

Clinical and Laboratory Assessment of Iron Overload in Sickle Cell Anemia and Sickle Cell Thalassemia Using T2* Cardiac MRI.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00512226
• Other study ID #: 0037-07-EMC
• 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

Related Conditions & MeSH terms

• Anemia
• Anemia, Sickle Cell
• Iron Overload
• MRI
• Sickle Cell Anemia
• Sickle Cell Thalassemia
• Thalassemia

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