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Liver Fibrosis in Sickle Cell Disease

NCT02007746 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 26

Last updated 2021-05-26

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Liver transient elastography (Fibroscan)

Fibroscan will be performed as a measure of liver stiffness. The study will be obtained free of charge in this study.

OTHER

Ferriscan

Ferriscan will be done to assess the quantity of liver iron in iron overloaded subjects.

PROCEDURE

Liver biopsy in iron overloaded subjects.

Liver biopsy will be done and the results will be compared to Fibroscan results.

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Ofelia Alvarez, MD · University of Miami - Director Sickle Cell Services Pediatric Hematology/Oncology

Eligibility

Min Age
10 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2017-06-01
Completion
2017-06-01

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02007746 on ClinicalTrials.gov