- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00512226
Iron Overload Assesment in Sickle Cell Anemia and Sickle Cell Thalassemia
August 25, 2011 updated by: Dr Koren Ariel, HaEmek Medical Center, Israel
Clinical and Laboratory Assessment of Iron Overload in Sickle Cell Anemia and Sickle Cell Thalassemia Using T2* Cardiac MRI.
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Afula, Israel, 18101
- Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of Iron overload.
Time Frame: December 2008
|
December 2008
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Institute the criteria for iron chelator treatment
Time Frame: December 2008
|
December 2008
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
August 5, 2007
First Submitted That Met QC Criteria
August 6, 2007
First Posted (Estimate)
August 7, 2007
Study Record Updates
Last Update Posted (Estimate)
August 26, 2011
Last Update Submitted That Met QC Criteria
August 25, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0037-07-EMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on MRI
-
Rennes University HospitalRecruiting
-
Fondation Ophtalmologique Adolphe de RothschildRecruiting
-
Fondation Ophtalmologique Adolphe de RothschildCompleted
-
University of LiegeUnknown
-
Centre Hospitalier Universitaire de NīmesRecruiting
-
PfizerCompletedMRI SedationUnited States, Japan
-
University of UtahWithdrawnMRI ScansUnited States
-
SpinTech, Inc.University of Iowa; University of Texas Southwestern Medical Center; Loma Linda... and other collaboratorsCompleted
Clinical Trials on Cardiac and Liver T2* MRI
-
Weill Medical College of Cornell UniversityNovartis PharmaceuticalsCompletedMyelodysplastic Syndrome (MDS)United States
-
St. Jude Children's Research HospitalCompletedHematological DiseasesUnited States
-
Bryan AllenNational Cancer Institute (NCI); Holden Comprehensive Cancer CenterRecruiting
-
Central Hospital, Nancy, FranceCompletedHeart Transplantation | Acute Graft RejectionFrance
-
University Hospital, LilleCompleted
-
Istituto Ortopedico RizzoliWithdrawn
-
Universitaire Ziekenhuizen KU LeuvenKing's College LondonCompletedPulmonary Hypertension | Cardiomyopathy, Dilated | Constrictive Pericarditis | Cardiomyopathy, Congestive
-
Fondation Ophtalmologique Adolphe de RothschildCompleted
-
Seoul National University HospitalGuerbetActive, not recruitingLiver Cirrhosis | Hepatocellular Carcinoma | Chronic HepatitisKorea, Republic of
-
University of FloridaOcala Royal DamesActive, not recruitingBreast CancerUnited States