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

October 31, 2025 updated by: Heidi Yeh, Massachusetts General Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Brigham
        • Contact:
        • Contact:
          • Emily Nyhan, CRC II, MS
          • Phone Number: 617-643-6266
          • Email: enyhan@mgb.org
        • Principal Investigator:
          • Heidi Yeh, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Early allograft dysfunction
Time Frame: First week after transplant
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intraoperative inotropic support
Time Frame: At reperfusion, 15 minutes, 1 hour, 2 hours, and 3 hours after reperfusion
Number of participants in need of inotropic support to maintain hemodynamics intraoperatively after reperfusion of liver allograft
At reperfusion, 15 minutes, 1 hour, 2 hours, and 3 hours after reperfusion
Need for post-operative inotropic support
Time Frame: First 30 days post-transplantation
Number of participants in need of inotropic support upon admission to the ICU
First 30 days post-transplantation
Length of post-operative inotropic support
Time Frame: First 30 days post-transplantation
Length of inotropic support used after admission to the ICU, if needed
First 30 days post-transplantation
Need for post-operative mechanical ventilation
Time Frame: First 30 days post-transplantation
Number of participants in need of mechanical ventilation upon admission to ICU
First 30 days post-transplantation
Length of post-operative mechanical ventilation
Time Frame: First 30 days post-transplantation
Length of intubation after admission to ICU, if mechanical ventilation needed
First 30 days post-transplantation
ICU length of stay
Time Frame: First 30 days post-transplantation
Length of stay in ICU post-transplant
First 30 days post-transplantation
Renal replacement therapy requirement
Time Frame: First 30 days post-transplantation
Number of participants who require renal replacement therapy during the first 10 days after liver transplantation, if not on renal replacement prior to transplant
First 30 days post-transplantation
Peak AST and ALT
Time Frame: First 7 days post-transplantation
Concentration of peak AST and ALT
First 7 days post-transplantation
Internal Normalized Ratio (INR)
Time Frame: First 7 days post-transplantation or within first 30 days post-op if discharge is longer than 7 days out
INR measurements for each participant until post-op day 7 or discharge
First 7 days post-transplantation or within first 30 days post-op if discharge is longer than 7 days out
Total bilirubin
Time Frame: First 7 days post-transplantation or within first 30 days post-op if discharge is longer than 7 days out
Total bilirubin measurement (mg/dl) on post-op day 7 or day of discharge
First 7 days post-transplantation or within first 30 days post-op if discharge is longer than 7 days out
30-day patient survival
Time Frame: First 30 days post-transplantation
30-day patient survival (percentage)
First 30 days post-transplantation
Re-listing for transplantation
Time Frame: First 30 days post-transplantation
Number of participants who require re-listing for liver transplantation within 30 days post-op
First 30 days post-transplantation
Adverse events
Time Frame: First 30 days post-transplantation
Incidence of any additional adverse events, not including 24-hour ICU stay post-transplant, post-transplant transfusion <=6 units pRBCs, <=2 units FFP, <=2 units 6-pack of platelets, as these are considered routine
First 30 days post-transplantation
Biopsy-proven rejection episodes
Time Frame: Assessed at 3, 6, and 12 months post-transplant
Number of participants with biopsy-proven rejection episodes
Assessed at 3, 6, and 12 months post-transplant
Liver function tests more than 3 times normal
Time Frame: Assessed at 3, 6, and 12 months post-transplant
Number of participants with liver function tests more than 3 times normal; liver function tests (LFTs) will measure AST/ALT, bilirubin, INR
Assessed at 3, 6, and 12 months post-transplant
Additional procedures
Time Frame: Assessed at 3, 6, and 12 months post-transplant
Number of participants that require additional procedures beyond normal recovery standard of care post-liver transplant
Assessed at 3, 6, and 12 months post-transplant
Re-admissions
Time Frame: Assessed at 3, 6, and 12 months post-transplant
Number of participants with re-admissions after initial discharge
Assessed at 3, 6, and 12 months post-transplant
Ischemic cholangiopathy and anastomotic strictures by imaging
Time Frame: Assessed at 3, 6, and 12 months post-transplant
Number of participants with evidence of ischemic cholangiopathy and anastomotic strictures by imaging
Assessed at 3, 6, and 12 months post-transplant
Vascular complications by cross-sectional imaging or angiography
Time Frame: Assessed at 3, 6, and 12 months post-transplant
Number of participants with evidence of vascular complications by cross-sectional imaging or angiography
Assessed at 3, 6, and 12 months post-transplant
Presence of steatosis by imaging or histology
Time Frame: Assessed at 3, 6, and 12 months post-transplant
Number of participants with evidence of steatosis by imaging or histology
Assessed at 3, 6, and 12 months post-transplant
Degree of steatosis by imaging or histology
Time Frame: Assessed at 3, 6, and 12 months post-transplant
Degree of steatosis by imaging or histology, if present
Assessed at 3, 6, and 12 months post-transplant
Renal dysfunction
Time Frame: Assessed at 3, 6, and 12 months post-transplant
Presence of a decrease in GFR > 40 from pre-transplant baseline or creatinine >2 if received simultaneous liver-kidney transplant
Assessed at 3, 6, and 12 months post-transplant
Hyperlipidemia
Time Frame: Assessed at 3, 6, and 12 months post-transplant
Number of participants with evidence of hyperlipidemia
Assessed at 3, 6, and 12 months post-transplant
Immunosuppression medications
Time Frame: Assessed at 3, 6, and 12 months post-transplant
Types of immunosuppression medications required
Assessed at 3, 6, and 12 months post-transplant
Dosage of immunosuppression medications
Time Frame: Assessed at 3, 6, and 12 months post-transplant
Dosage of immunosuppression medications required in respective unit measurement (i.e. milligrams)
Assessed at 3, 6, and 12 months post-transplant
Drug levels of immunosuppression medications
Time Frame: Assessed at 3, 6, and 12 months post-transplant
Drug levels of immunosuppression medications present in blood titers drawn from participant in respective unit measurement (i.e. ng/mL)
Assessed at 3, 6, and 12 months post-transplant
Re-listing for transplantation
Time Frame: Assessed at 3, 6, and 12 months post-transplant
Number of participants who require re-listing for transplantation within 1 year post-op
Assessed at 3, 6, and 12 months post-transplant
Graft failure
Time Frame: Assessed at 3, 6, and 12 months post-transplant
Number of participants with evidence of graft failure
Assessed at 3, 6, and 12 months post-transplant
Patient death
Time Frame: Assessed at 3, 6, and 12 months post-transplant
Number of participants with evidence of patient death
Assessed at 3, 6, and 12 months post-transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023P002561

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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