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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06088758
Status
Recruiting
Apply to this trial

Conditions

  • Liver Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Feb 28, 2024
Status verified
Oct 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General BrighamBostonMassachusetts02114
Olivia Bourgeois, CRC II, BS
[email protected]
617-724-1976
Emily Nyhan, CRC II, MS
[email protected]
617-643-6266
Heidi Yeh, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Massachusetts General Brigham· Boston, MA

Related Studies