Developing Viability Index for Machine Perfused Livers

Development of a Liver Viability Index for Transplantation

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03694691

Enrollment

Registered

2018-10-03

Start date

2018-10-01

Completion date

2030-06-01

Last updated

2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhoses

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.

Interventions

DIAGNOSTIC_TESTLiver 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Seropositivity for HIV-1.

Design outcomes

Primary

Measure	Time frame	Description
Peak transaminase value post transplant	1 Year	The primary endpoint is peak transaminase values since transaminase elevation is a marker of hepatocyte injury

Secondary

Measure	Time frame
Incidence of major Infection	1 Year
Hepatitis C Recurrence (in Hepatitis C positive recipients)	1 Year
Kidney Failure	1 Year
Acute Liver Rejection	1 Year
Liver Graft Failure	1 Year
Death	1 Year
Biliary Complications	1 Year

Countries

United States

Contacts

Primary ContactHeidi Yeh, MD

hyeh@mgh.harvard.edu617-726-3664

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026