Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT03694691

Conditions

Liver Cirrhoses

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Liver Biopsy

Study Details

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.

Conditions

Liver Cirrhoses

Study ID

NCT03694691

Start date

Oct 1, 2018

Status verified date

Oct, 2025

Completion date

Jun 1, 2030

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Seropositivity for HIV-1.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Biopsy

Biopsies taken at protocol specified time points

Interventions

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.

Primary outcome measure

  • Peak transaminase value post transplant [ Time Frame: 1 Year ]

Central Contacts and Locations

Central contacts

Heidi Yeh, MD

617-726-3664hyeh@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Nov 3, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-11-03.