Developing Viability Index for Machine Perfused Livers

Mass General Brigham

Status: Enrolling

Conditions: Liver Cirrhoses

Treatments: Diagnostic Test: Liver Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT03694691

Liver Perfusion ATP

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Seropositivity for HIV-1.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Biopsy

Experimental group

Description:

Biopsies taken at protocol specified time points

Treatment:

Diagnostic Test: Liver Biopsy