Recruiting

Normothermic Machine Perfusion

Sponsor:

Massachusetts General Hospital

Code:

NCT06088758

Conditions

Liver Transplant

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Normothermic machine perfusion (NMP) of steatotic liver

Study Details

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

Study ID

NCT06088758

Start date

Feb 28, 2024

Status verified date

Oct, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Liver Transplantation with Steatotic Liver

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

Interventions

Normothermic machine perfusion (NMP) of steatotic liver

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

Primary outcome measure

  • Early allograft dysfunction [ Time Frame: First week after transplant ]

Central Contacts and Locations

Central contacts

Heidi Yeh, MD

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

Locations

Massachusetts General Brigham

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Olivia Bourgeois, CRC II, BS

617-724-1976obourgeois@mgb.org

Emily Nyhan, CRC II, MS

617-643-6266enyhan@mgb.org

Principal Investigator:

Heidi Yeh, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Nov 3, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-11-03.