Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE August 5, 2007
First Posted Date  ICMJE August 7, 2007
Last Update Posted Date August 26, 2011
Study Start Date  ICMJE September 2007
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2009)
Assessment of Iron overload. [ Time Frame: December 2008 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 6, 2007)
Assessment of Iron overload.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2009)
Institute the criteria for iron chelator treatment [ Time Frame: December 2008 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2007)
Institute the criteria for iron chelator treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Iron Overload Assesment in Sickle Cell Anemia and Sickle Cell Thalassemia
Official Title  ICMJE Clinical and Laboratory Assessment of Iron Overload in Sickle Cell Anemia and Sickle Cell Thalassemia Using T2* Cardiac MRI.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Sickle Cell Anemia
  • Sickle Cell Thalassemia
  • Iron Overload
  • MRI
Intervention  ICMJE Other: Cardiac and Liver T2* MRI
Laboratory examinations that are routinely used in follow up of those patients and T2* MRI analysis.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 6, 2007)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00512226
Other Study ID Numbers  ICMJE 0037-07-EMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Koren Ariel, HaEmek Medical Center, Israel
Study Sponsor  ICMJE HaEmek Medical Center, Israel
Collaborators  ICMJE Wolfson Medical Center
Investigators  ICMJE
Principal Investigator: Ariel Koren, MD Pediatric Hematology Unit, Ha'Emek Medical Center
PRS Account HaEmek Medical Center, Israel
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP