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Recruiting NCT06088758

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

No phase Interventional Liver Transplant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Normothermic machine perfusion (NMP) of steatotic liver.
Who it may be relevant to
Registry conditions: Liver Transplant. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Early allograft dysfunction [Time frame: First week after transplant]
Secondary outcome measures (12)
  • Intraoperative inotropic support [Time frame: 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]
  • Length of post-operative inotropic support [Time frame: First 30 days post-transplantation]
  • Need for post-operative mechanical ventilation [Time frame: First 30 days post-transplantation]
  • Length of post-operative mechanical ventilation [Time frame: First 30 days post-transplantation]
  • ICU length of stay [Time frame: First 30 days post-transplantation]
  • Renal replacement therapy requirement [Time frame: First 30 days post-transplantation]
  • Peak AST and ALT [Time frame: 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]
  • Total bilirubin [Time frame: 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]
  • Re-listing for transplantation [Time frame: First 30 days post-transplantation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Massachusetts General Brigham — Boston

Identifiers

NCT: NCT06088758 · 2023P002561

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗