NCT00629291

Brief Summary

Sickle cell anemia and Sickle cell β thalassemia patients require multiple transfusions in order to avoid chronic anemia sequel. This regimen entails intrinsic deleterious effects, the majority of which are related to iron deposition in the reticuloendothelial system. Thus, iron is deposited in hepatic, myocardial and endocrine glands tissues. Tools available for iron load evaluation include serum ferrtin levels, liver biopsy and echocardiography, all are non specific. The purpose of this work is to compare iron overload in the liver, heart and pancreas in Sickle cell anemia and Sickle cell β thalassemia patients using T2\* MRI sequences.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2008

Typical duration for all trials

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

Study Start

First participant enrolled

January 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

May 11, 2010

Status Verified

May 1, 2010

Enrollment Period

2.3 years

First QC Date

February 25, 2008

Last Update Submit

May 9, 2010

Conditions

Iron Overload

Keywords

iron overloadThalassemiaAnemia, Sickle CellMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • outcome measure: iron overload on T2* MRI in the heart , liver and pancreas.

    1 year

Study Arms (2)

1

Sickle cell anemia patients

2

Sickle cell β thalassemia

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Sickle cell anemia and Sickle cell β thalassemia patients from dedicated outpatient hospital clinic.

You may qualify if:

  • clinical diagnosis of Sickle cell anemia or Sickle cell β thalassemia having received multiple blood transfusions.

You may not qualify if:

  • contraindication to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center , Imaging Dept

Tel Litwinsky, Tel Hashomer, 52621, Israel

Location

Biospecimen

Retention: NONE RETAINED

No biosepcimens retained

MeSH Terms

Conditions

Iron OverloadThalassemiaAnemia, Sickle Cell

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Orly Goitein, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 25, 2008

First Posted

March 5, 2008

Study Start

January 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

May 11, 2010

Record last verified: 2010-05

Locations

IL(1)