Normothermic Machine Perfusion of Steatotic Livers for Expansion of Donor Organ Pool

Mass General Brigham

Status: Enrolling

Conditions: Liver Transplant

Treatments: Device: Normothermic machine perfusion (NMP) of steatotic liver

Study type: Interventional

Funder types: Other

Identifiers

NCT06088758

2023P002561

Details and patient eligibility

About

The goal of this clinical trial is to assess the ability of Normothermic Machine Perfusion (NMP) to resuscitate moderately steatotic livers for transplantation in patients. This will be a single-site clinical trial placing donor livers with 30-60% macrosteatosis on NMP, and then transplanting those that meet commonly accepted viability criteria. The results of this study could lead to a trial extending NMP transplantation to severely steatotic livers, further expanding the donor organ pool.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-80 years
• Listed for liver transplantation at MGH
• Calculated MELD-Na score <= 25
• Able to consent

Exclusion criteria

• Status 1a
• Cardiac or pulmonary disease
• Prior liver transplant
• Requiring pressors at the time of liver offer
• MELD<15 and asymptomatic from liver disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Liver Transplantation with Steatotic Liver

Experimental group

Description:

Graft will be selected if 30-60% macrosteatosis and transplanted into liver transplant recipient with MELD of 15-25.

Treatment:

Device: Normothermic machine perfusion (NMP) of steatotic liver