Developing Viability Index for Machine Perfused Livers
Development of a Liver Viability Index for Transplantation
1 other identifier
interventional
60
1 country
1
Brief Summary
Machine perfusion technology is nearing the point of rescuing discarded liver grafts in the hope of proving them to be or improving them to the point of being transplantable. However, there are no validated metrics to determine transplantability after machine perfusion. This study involves collecting biopsies from transplanted livers before and after implantation to correlate metabolite and gene expression with post-transplant function. This data will help develop a viability index for machine perfused livers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedFirst Posted
Study publicly available on registry
October 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
November 3, 2025
October 1, 2025
10.2 years
September 26, 2018
October 31, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Peak transaminase value post transplant
The primary endpoint is peak transaminase values since transaminase elevation is a marker of hepatocyte injury
1 Year
Secondary Outcomes (7)
Acute Liver Rejection
1 Year
Incidence of major Infection
1 Year
Hepatitis C Recurrence (in Hepatitis C positive recipients)
1 Year
Kidney Failure
1 Year
Biliary Complications
1 Year
- +2 more secondary outcomes
Study Arms (1)
Biopsy
EXPERIMENTALBiopsies taken at protocol specified time points
Interventions
For measurement of tissue co-factor levels, we will take needle biopsies of transplanted livers immediately after procurement, immediately prior to implantation (at the end of preservation), 30 minutes after portal vein reperfusion, and 30 minutes after hepatic artery reperfusion. For those livers that have more than 60 minutes between portal vein and hepatic artery reperfusion, an additional biopsy will be performed at 60 minutes after portal vein reperfusion. Post-procurement biopsies will be collected regardless of where the liver was obtained.
Eligibility Criteria
You may qualify if:
- Male or female 18-75 years of age.
- Candidate for a deceased-donor liver allograft.
You may not qualify if:
- Seropositivity for HIV-1.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Brigham and Women's Hospitalcollaborator
- Shriners Hospitals for Childrencollaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Heidi Yeh, MD
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 26, 2018
First Posted
October 3, 2018
Study Start
October 1, 2018
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
June 1, 2030
Last Updated
November 3, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share