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NCT Number: NCT03694691

Developing Viability Index for Machine Perfused Livers

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.

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Key information

Conditions

Liver Cirrhoses

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Heidi Yeh

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Seropositivity for HIV-1.

Treatment and study plan

Liver biopsy

Diagnostic Test

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.

Primary outcomes

  1. Peak transaminase value post transplant

    Time frame: 1 Year

    The primary endpoint is peak transaminase values since transaminase elevation is a marker of hepatocyte injury

Secondary outcomes

  1. Acute Liver Rejection

    Time frame: 1 Year

  2. Incidence of major Infection

    Time frame: 1 Year

  3. Hepatitis C Recurrence (in Hepatitis C positive recipients)

    Time frame: 1 Year

  4. Kidney Failure

    Time frame: 1 Year

  5. Biliary Complications

    Time frame: 1 Year

  6. Liver Graft Failure

    Time frame: 1 Year

  7. Death

    Time frame: 1 Year

Study contacts

Contact information is provided by the study sponsor or research team.

Heidi Yeh, MD

CONTACT

[email protected]

617-726-3664

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Brigham and Women's Hospital
  • Shriners Hospitals for Children

Registry information

Official study title

Development of a Liver Viability Index for Transplantation

Important dates

Study start
2018
Primary completion
2028
Study completion
2030
First posted
Oct 3, 2018
Registry last updated
Nov 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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