Back to resultsIron Overload Assesment in Sickle Cell Anemia and Sickle Cell Thalassemia
Primary Purpose
Sickle Cell Anemia, Sickle Cell Thalassemia, Iron Overload
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Cardiac and Liver T2* MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Sickle Cell Anemia focused on measuring Sickle Cell Anemia, Sickle Cell Thalassemia, Iron Overload, MRI
Eligibility 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.
Sites / Locations
- Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center
Outcomes
Primary Outcome Measures
Assessment of Iron overload.
Secondary Outcome Measures
Institute the criteria for iron chelator treatment
Full Information
NCT ID
NCT00512226
First Posted
August 5, 2007
Last Updated
August 25, 2011
Sponsor
HaEmek Medical Center, Israel
Collaborators
Wolfson Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00512226
Brief Title
Iron Overload Assesment in Sickle Cell Anemia and Sickle Cell Thalassemia
Official Title
Clinical and Laboratory Assessment of Iron Overload in Sickle Cell Anemia and Sickle Cell Thalassemia Using T2* Cardiac MRI.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel
Collaborators
Wolfson Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Anemia, Sickle Cell Thalassemia, Iron Overload, MRI
Keywords
Sickle Cell Anemia, Sickle Cell Thalassemia, Iron Overload, MRI
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Cardiac and Liver T2* MRI
Intervention Description
Laboratory examinations that are routinely used in follow up of those patients and T2* MRI analysis.
Primary Outcome Measure Information:
Title
Assessment of Iron overload.
Time Frame
December 2008
Secondary Outcome Measure Information:
Title
Institute the criteria for iron chelator treatment
Time Frame
December 2008
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariel Koren, MD
Organizational Affiliation
Pediatric Hematology Unit, Ha'Emek Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Iron Overload Assesment in Sickle Cell Anemia and Sickle Cell Thalassemia
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