Developing Viability Index for Machine Perfused Livers

Conditions

• Liver Cirrhoses

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Oct 1, 2018

Status verified

Oct 2025

Primary completion

Dec 1, 2028

Completion

Jun 1, 2030

Study Design

Enrollment

60 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Biopsy
  Biopsies taken at protocol specified time points

Primary Outcome Measure

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

Central Contacts

• Heidi Yeh, MD
  617-726-3664
  [email protected]

Locations (1)

Find similar trials in Boston, MA

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