NCT00512226

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2007

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 26, 2011

Status Verified

August 1, 2011

Enrollment Period

3.3 years

First QC Date

August 5, 2007

Last Update Submit

August 25, 2011

Conditions

Sickle Cell AnemiaSickle Cell ThalassemiaIron OverloadMRI

Keywords

Sickle Cell AnemiaSickle Cell ThalassemiaIron OverloadMRI

Outcome Measures

Primary Outcomes (1)

  • Assessment of Iron overload.

    December 2008

Secondary Outcomes (1)

  • Institute the criteria for iron chelator treatment

    December 2008

Interventions

Cardiac and Liver T2* MRIOTHER

Laboratory examinations that are routinely used in follow up of those patients and T2\* MRI analysis.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All the patients with Sickle cell anemia and Sickle cell Thalasemia that are currently in follow up at the Pediatric Hematology Unit

You may not qualify if:

  • Age below 18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center

Afula, 18101, Israel

Location

MeSH Terms

Conditions

Anemia, Sickle CellIron Overload

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ariel Koren, MD

    Pediatric Hematology Unit, Ha'Emek Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Pediatric Hematology Unit and Pediatric Dpt B

Study Record Dates

First Submitted

August 5, 2007

First Posted

August 7, 2007

Study Start

September 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

August 26, 2011

Record last verified: 2011-08

Locations

IL(1)