Using machine perfusion to improve liver transplants from steatotic donors
Normothermic Machine Perfusion of Steatotic Livers for Expansion of Donor Organ Pool
This study is testing if a special machine can help make fatty livers from donors healthier for transplantation so more people can receive liver transplants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06088758 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Normothermic Machine Perfusion (NMP) in resuscitating moderately steatotic livers for transplantation. The study will involve placing donor livers with 30-60% macrosteatosis on NMP and subsequently transplanting those that meet established viability criteria. By successfully demonstrating the viability of these livers, the trial could pave the way for future studies to include severely steatotic livers, thereby expanding the donor organ pool for liver transplants.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18-80 who are listed for liver transplantation and have a MELD-Na score of 25 or lower.
Not a fit: Patients with severe liver disease requiring immediate transplantation or those with significant cardiac or pulmonary conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly increase the availability of donor livers for transplantation, potentially saving more lives.
How similar studies have performed: While the use of machine perfusion in organ transplantation is gaining traction, this specific approach targeting moderately steatotic livers is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Brigham — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Heidi Yeh, MD
- Email: hyeh@mgh.harvard.edu
- Phone: 617-643-4533
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.