Clinical and Laboratory Assessment of Iron Overload in Sickle Cell Anemia and Sickle Cell Thalassemia

• ClinicalTrials.gov Identifier: NCT00512564
• Recruitment Status: Completed
• First Posted: August 7, 2007
• Last Update Posted: August 26, 2011
• Sponsor: HaEmek Medical Center, Israel
• Information provided by (Responsible Party): Dr Koren Ariel, HaEmek Medical Center, Israel

Tracking Information

• First Submitted Date: August 5, 2007
• First Posted Date: August 7, 2007
• Last Update Posted Date: August 26, 2011
• Study Start Date: September 2008
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical and Laboratory Assessment of Iron Overload 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 - An Observational and Laboratory Study
• 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 developed significant clinical symptoms and signs of iron overload in spite frequent transfusions. The purpose of this study is to assess the iron overload in Sickle cell anemia and Sickle cell Thalassemia patients using clinical parameters and laboratory studies including Non Transferrin Binding Iron, Labile Iron and Hepcidin, in order to determine the cardiac and liver iron.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: All tha patinets suffering from Sickle cell disease trreated at the Pediatric Hematology Unit

Condition

• Sickle Cell Anemia
• Sickle Cell Thalassemia

Intervention

Other: Laboratory analyses of iron overload

Summary of clinical status related to iron overload and laboratory analysis of Iron overload including Total serum Iron, Transferrin, Ferritin and Non transferrin Binding Iron and Labile Plasma Iron

Study Groups/Cohorts

1

Patients suffering from Sickle cell disease

Intervention: Other: Laboratory analyses of iron overload

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: August 6, 2007): 50
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2010
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• All the patients with Sickle Cell Anemia and Sickle Cell Thalassemia that are treated and followed up at the Pediatric Hematology Unit.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT00512564
• Other Study ID Numbers: 0087-07-EMC
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Dr Koren Ariel, HaEmek Medical Center, Israel
• Original Responsible Party: Not Provided
• Current Study Sponsor: HaEmek Medical Center, Israel
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ariel Koren, MD; Pediatric Hematology Unit, Ha'Emek Medical Center

• PRS Account: HaEmek Medical Center, Israel
• Verification Date: August 2011