N/A
Completed N=160
Controlled Attenuation Parameter (CAP) in Liver Allografts
Liver transplant · Liver Steatosis · Liver disease · Primary Non-function
Source: ClinicalTrials.gov NCT02798861 ↗
Enrolled (actual)
160
Serious AEs
—
Results posted
Jul 2020
Primary outcomePrimary: Controlled Attenuation Parameter (CAP) - Accuracy — 220 dB/m
Summary
The primary aim is to determine the accuracy of CAP in the quantification of liver steatosis using liver biopsies as reference. Secondarily, investigators will correlate transient elastography (TE) and CAP results, analyze possible associations between CAP/TE and post-liver transplant (LT) clinical outcomes, and evaluate the change in CAP after LT. The study aims to include as many donors as needed to achieve at least 120 transplanted liver allografts.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Controlled Attenuation Parameter (CAP) - Accuracy |
220 | — |
| SECONDARY LSM |
6 | — |
Eligibility Criteria
Inclusion criteria - Liver Recipient
- Men and women, Age 18-years old to 80-years old inclusive
Inclusion criteria - Liver Donor
- Valid TE with Fibroscan 402/530, defined as:
- At least 10 valid measurements
- IQR/Median stiffness value 7.1 kPa)
Exclusion criteria - Liver Recipient
- Patient did not undergo liver transplantation
Exclusion criteria - Liver Donor
- Donation after circulatory death (DCD)
- No liver biopsy obtained during organ procurement process
Data sourced from ClinicalTrials.gov (NCT02798861). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.