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

NCT06088758 | Recruiting DMC FDA Device

• 1 other identifier: 2023P002561
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Transplant

Outcome Measures

Primary Outcomes (1)

• Early allograft dysfunction

  Number of participants with initial poor function of liver allograft: measured by presence of 1 or more of the following: aspartate aminotransferase (AST) level higher than 2000 IU/L (to convert to microkatals per liter, multiply by 0.0167) within the first 7 postoperative days; bilirubin 10 mg/dL or higher (to convert to micromoles per liter, multiply by 17.104) on postoperative day 7; international normalized ratio (INR) of 1.6 or higher on postoperative day 7; or graft primary nonfunction within the first 7 days, defined as irreversible graft dysfunction leading to recipient death or emergency retransplant, in the absence of immunologic or surgical causes

  First week after transplant

Secondary Outcomes (29)

• Intraoperative inotropic support

  At reperfusion, 15 minutes, 1 hour, 2 hours, and 3 hours after reperfusion

• Need for post-operative inotropic support

  First 30 days post-transplantation

• Length of post-operative inotropic support

  First 30 days post-transplantation

• Need for post-operative mechanical ventilation

  First 30 days post-transplantation

• Length of post-operative mechanical ventilation

  First 30 days post-transplantation

Study Arms (1)

Liver Transplantation with Steatotic Liver

EXPERIMENTAL

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

Device: Normothermic machine perfusion (NMP) of steatotic liver

Interventions

Normothermic machine perfusion (NMP) of steatotic liver DEVICE

Steatotic liver grafts that are selected will be run on NMP to assess quality of graft and determine whether it meets criteria for transplantation

Liver Transplantation with Steatotic Liver

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Brigham

Boston, Massachusetts, 02114, United States

RECRUITING

Central Study Contacts

Heidi Yeh, MD

CONTACT

617-643-4533; hyeh@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 18, 2023
• Study Start: February 28, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)