Developing a Viability Index for Machine Perfused Livers

This study is looking at how well livers preserved using a special machine (machine perfusion) work after transplant. Currently, there isn't a clear way to tell if these machine-preserved livers are good enough for transplant. Researchers will take small tissue samples (biopsies) from transplanted livers at different times: right after they are removed from the donor, before they are put into the patient, and after they are connected inside the patient. They will then look at these samples to see how the liver is functioning. The goal is to create a way to predict how well a machine-preserved liver will work after transplant. You may be able to join if you are between 18 and 75 years old and are scheduled to receive a liver transplant from a deceased donor. The study will measure how well your liver is working one year after transplant. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 60 participants. It is not specified if it is randomized or blinded.
What's involved
You would have small tissue samples (liver biopsies) taken from your transplanted liver at four different times: after procurement, before implantation, and 30 minutes after two different blood vessel connections during surgery.
Compensation
Not stated in the trial record.
Follow-up
Your liver function will be measured for up to one year after the transplant.

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NCT03694691

Developing Viability Index for Machine Perfused Livers

Recruiting
NAAges 18–75InterventionalDiagnostic
Massachusetts General Hospital
~60 participants
Updated 2025-11-03 on ClinicalTrials.gov
What's tested:Liver Biopsy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Peak transaminase value post transplant
Measured over 1 Year
Liver Cirrhoses
1 sites across 1 states
Massachusetts1
  • Heidi Yeh, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

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Eligibility criteria

Inclusion

Male or female 18-75 years of age.
Candidate for a deceased-donor liver allograft.

Exclusion

Seropositivity for HIV-1.
  • Peak transaminase value post transplant1 Year

    The primary endpoint is peak transaminase values since transaminase elevation is a marker of hepatocyte injury