Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years
- Candidate for a deceased-donor liver allograft
You will not qualify if you...
- Seropositivity for HIV-1
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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
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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