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Developing Viability Index for Machine Perfused Livers

NCT03694691 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-11-03

No results posted yet for this study

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.

Conditions

  • Liver Cirrhoses

Interventions

DIAGNOSTIC_TEST

Liver Biopsy

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.

Sponsors & Collaborators

  • Brigham and Women's Hospital

    collaborator OTHER

  • Shriners Hospitals for Children

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Heidi Yeh, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2028-12-01
Completion
2030-06-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03694691 on ClinicalTrials.gov