RecruitingNot ApplicableNCT03694691

Developing Viability Index for Machine Perfused Livers

Development of a Liver Viability Index for Transplantation

Sponsor

Massachusetts General Hospital

Enrollment

60 participants

Start Date

Oct 1, 2018

Study Type

INTERVENTIONAL

Conditions

Liver Cirrhoses

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is developing a test (a "viability index") to predict whether a donated liver being kept alive outside the body using a machine (machine perfusion) is suitable for transplantation, with the goal of helping doctors decide which livers are safe and ready to transplant. **You may be eligible if...** - You are between 18 and 75 years old - You are on the waiting list for a deceased-donor liver transplant **You may NOT be eligible if...** - You test positive for HIV-1 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.