CompletedNot Applicable

Controlled Attenuation Parameter (CAP) in Liver Allografts

United States160 participantsStarted 2016-09-07

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 \<30% (only in cases with \>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

What they're measuring

Controlled Attenuation Parameter (CAP) - Accuracy

Timeframe: Baseline (pre-procurement) to 6 months post liver transplant

Trial details

NCT IDNCT02798861

SponsorAndres Duarte-Rojo

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-06-01

Results submitted2020-06-02

View on ClinicalTrials.gov More Liver Transplant trials