Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID03694691

Development of a Liver Viability Index for Transplantation

Led by Massachusetts General Hospital · Updated on 2025-11-03

60

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

B

Brigham and Women's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of machine perfusion technology to improve the transplantability of discarded liver grafts. The study aims to develop a liver viability index by collecting biopsies from transplanted livers before and after implantation to analyze metabolite and gene expression and their relationship to post-transplant liver function. This research focuses on patients with liver cirrhosis who are candidates for deceased-donor liver transplants. Participants will undergo liver biopsies at specific times: immediately after organ procurement, just before implantation, 30 minutes after portal vein reperfusion, and 30 minutes after hepatic artery reperfusion. If there is more than 60 minutes between these two reperfusions, an additional biopsy will be taken. These biopsies will help measure tissue co-factor levels and collect data for the viability index. During the study, participants will be monitored for liver function and complications up to one year post-transplant. Researchers will track outcomes such as peak liver enzyme levels, acute liver rejection, infections, hepatitis C recurrence (if applicable), kidney failure, biliary complications, graft failure, and death. This long-term follow-up will provide valuable information on the success of machine perfused liver transplants and the viability index.

CONDITIONS

Brief Title

Developing Viability Index for Machine Perfused Livers

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 to 75 years
  • Candidate for a deceased-donor liver allograft
Not Eligible

You will not qualify if you...

  • Seropositivity for HIV-1

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Day of transplantation

Participants undergo liver biopsies at specified time points around transplantation to measure tissue co-factor levels.

Multiple biopsy procedures during transplantation day

Long-term Monitoring

Duration - 1 year

Participants are monitored for outcomes such as liver function, rejection, infection, and graft survival over one year after transplantation.

Periodic follow-up visits up to 1 year post-transplant

Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

H

Heidi Yeh, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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