Health TrialsbyHealthPanel

Developing Viability Index for Machine Perfused Livers

ConditionLiver Cirrhoses
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMassachusetts General Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female 18-75 years of age.

Candidate for a deceased-donor liver allograft.

Disqualifiers

Seropositivity for HIV-1.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: BiopsyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Peak transaminase value post transplant

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

Time frame
1 Year

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Brigham and Women's Hospital

Collaborator

Shriners Hospitals for Children

Collaborator

Source ClinicalTrials.gov
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