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NCT02007746 · ClinicalTrials.gov registry record
Liver Fibrosis in Sickle Cell Disease
A clinical trial, sponsored by University of Miami.
- Completed
- Registry status
- 26
- Enrollment target
NCT02007746: Completed study, sponsored by University of Miami.
NCT02007746 is a clinical trial that has completed, run by University of Miami. The registered enrollment target is 26 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02007746 has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- 26 participants
- Enrollment target
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.
Primary Outcome
Liver transient elastography (FibroScan) uses a probe consisting of an ultrasound transducer located at the end of a vibrating piston. The piston produces a vibration of low amplitude and frequency, which generate a shear wave that passes through the skin and liver tissue. The ultrasound then detects the propagation of the shear wave through the liver (at a depth of 25 - 65 mm below the skin surface) by measuring its velocity. The shear wave velocity is directly related to the tissue stiffness,
Interventions
- OTHER Liver transient elastography (Fibroscan)
- OTHER Ferriscan
- PROCEDURE Liver biopsy in iron overloaded subjects.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2012-07 |
| Est. Completion | 2017-06-01 |
What the finished NCT02007746 record still lists
NCT02007746 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 26 participants, a relatively small participant target.
The record links to 0 conditions, and to 3 interventions - of which Liver transient elastography (Fibroscan) is the first listed.
NCT02007746 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02007746 about?
NCT02007746 is a clinical study titled "Liver Fibrosis in Sickle Cell Disease". 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 cel...
What is the current status of trial NCT02007746?
This trial is currently completed. The enrollment target is 26 participants. The study started on 2012-07. Estimated completion is 2017-06-01.
What interventions are being tested in trial NCT02007746?
The interventions under investigation include: Liver transient elastography (Fibroscan) (OTHER), Ferriscan (OTHER), Liver biopsy in iron overloaded subjects. (PROCEDURE).
Who is sponsoring clinical trial NCT02007746?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
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