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

NCT ID: NCT06088758

Last Updated: 2025-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-28

Study Completion Date

2027-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Transplant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Liver Transplantation with Steatotic Liver

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

Group Type EXPERIMENTAL

Normothermic machine perfusion (NMP) of steatotic liver

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Heidi Yeh

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massachusetts General Brigham

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Heidi Yeh, MD

Role: CONTACT

617-643-4533

Facility Contacts

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Olivia Bourgeois, CRC II, BS

Role: primary

617-724-1976

Emily Nyhan, CRC II, MS

Role: backup

617-643-6266

Other Identifiers

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2023P002561

Identifier Type: -

Identifier Source: org_study_id

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