Liver Fibrosis in Sickle Cell Disease
Completed
Conditions studied: Sickle Cell Disease
In brief
Patients with sickle cell disease many have a number of systemic complications, including liver problems. Some of these liver problems lead to liver fibrosis/cirrhosis, secondary to chronic blood transfusions. The purpose of this study is to investigate FibroScan readings in patients with sickle cell disease and iron overload secondary to blood transfusions, and to correlate the FibroScan results with Ferriscan. A comparison with the results of FibroScan to patients with Sickle cell without known liver disease, who have never been on chronic transfusions and with normal liver function profiles will also be made.The primary hypothesis is that the results of FibroScan will correlate with the results of Ferriscan and liver biopsy.
Key facts
- Study ID
- NCT02007746
- Run by
- University of Miami
- People needed
- 26
- Starts
- 2012-07-01
- Expected to finish
- 2017-06-01
- Last updated by the study team
- 2021-05-26
Who can join
Age: 10 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- pediatric patients age 10 years and older with sickle cell disease
- meeting other criteria:
- history of chronic transfusion and iron overload and/or
- known liver disease related to sickle cell or iron overload
- signed consent and assent (as applicable)
You may not qualify if…
- children younger than 10 years
- Pregnant females
- Prisoners
- Other causes of liver disease, unrelated to sickle cell or iron overload
- Inclusion criteria for controls:
- Patients 10 years and older with sickle cell disease without history of chronic transfusions (less than 4 transfusions in a lifetime)
- and without obvious liver disease.
Where it is running
- University of Miami — Miami, Florida, United States
Full record on ClinicalTrials.gov
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