Liver TransplantNCT06088758
Normothermic Machine Perfusion of Steatotic Livers for Expansion of Donor Organ Pool
A study testing Normothermic machine perfusion (NMP) of steatotic liver in people with Liver Transplant, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Transplant
- What is being tested?
- Normothermic machine perfusion (NMP) of steatotic liver
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- Listed for liver transplantation at MGH
- Calculated MELD-Na score <= 25
- Able to consent
Who cannot join
- Status 1a
- Cardiac or pulmonary disease
- Prior liver transplant
- Requiring pressors at the time of liver offer
- MELD<15 and asymptomatic from liver disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Brigham
Boston, Massachusetts, 02114
Olivia Bourgeois, CRC II, BS, 617-724-1976, obourgeois@mgb.org
Emily Nyhan, CRC II, MS, 617-643-6266, enyhan@mgb.org
About this study
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.
- Conditions
- Liver Transplant
- Being tested
- Normothermic machine perfusion (NMP) of steatotic liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normothermic machine perfusion (NMP) of steatotic liverDevice
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 group | Role | What they receive |
|---|---|---|
| Liver Transplantation with Steatotic Liver | Experimental | Graft will be selected if 30-60% macrosteatosis and transplanted into liver transplant recipient with MELD of 15-25. Receives: Device: Normothermic machine perfusion (NMP) of steatotic liver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early allograft dysfunction
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
Measured: First week after transplant
Secondary outcomes (29)
Intraoperative inotropic support
Number of participants in need of inotropic support to maintain hemodynamics intraoperatively after reperfusion of liver allograft
Measured: At reperfusion, 15 minutes, 1 hour, 2 hours, and 3 hours after reperfusion
Need for post-operative inotropic support
Number of participants in need of inotropic support upon admission to the ICU
Measured: First 30 days post-transplantation
Length of post-operative inotropic support
Length of inotropic support used after admission to the ICU, if needed
Measured: First 30 days post-transplantation
Need for post-operative mechanical ventilation
Number of participants in need of mechanical ventilation upon admission to ICU
Measured: First 30 days post-transplantation
Length of post-operative mechanical ventilation
Length of intubation after admission to ICU, if mechanical ventilation needed
Measured: First 30 days post-transplantation
ICU length of stay
Length of stay in ICU post-transplant
Measured: First 30 days post-transplantation
Renal replacement therapy requirement
Number of participants who require renal replacement therapy during the first 10 days after liver transplantation, if not on renal replacement prior to transplant
Measured: First 30 days post-transplantation
Peak AST and ALT
Concentration of peak AST and ALT
Measured: First 7 days post-transplantation
Internal Normalized Ratio (INR)
INR measurements for each participant until post-op day 7 or discharge
Measured: First 7 days post-transplantation or within first 30 days post-op if discharge is longer than 7 days out
Total bilirubin
Total bilirubin measurement (mg/dl) on post-op day 7 or day of discharge
Measured: First 7 days post-transplantation or within first 30 days post-op if discharge is longer than 7 days out
30-day patient survival
30-day patient survival (percentage)
Measured: First 30 days post-transplantation
Re-listing for transplantation
Number of participants who require re-listing for liver transplantation within 30 days post-op
Measured: First 30 days post-transplantation
Adverse events
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
Measured: First 30 days post-transplantation
Biopsy-proven rejection episodes
Number of participants with biopsy-proven rejection episodes
Measured: Assessed at 3, 6, and 12 months post-transplant
Liver function tests more than 3 times normal
Number of participants with liver function tests more than 3 times normal; liver function tests (LFTs) will measure AST/ALT, bilirubin, INR
Measured: Assessed at 3, 6, and 12 months post-transplant
Additional procedures
Number of participants that require additional procedures beyond normal recovery standard of care post-liver transplant
Measured: Assessed at 3, 6, and 12 months post-transplant
Re-admissions
Number of participants with re-admissions after initial discharge
Measured: Assessed at 3, 6, and 12 months post-transplant
Ischemic cholangiopathy and anastomotic strictures by imaging
Number of participants with evidence of ischemic cholangiopathy and anastomotic strictures by imaging
Measured: Assessed at 3, 6, and 12 months post-transplant
Vascular complications by cross-sectional imaging or angiography
Number of participants with evidence of vascular complications by cross-sectional imaging or angiography
Measured: Assessed at 3, 6, and 12 months post-transplant
Presence of steatosis by imaging or histology
Number of participants with evidence of steatosis by imaging or histology
Measured: Assessed at 3, 6, and 12 months post-transplant
Degree of steatosis by imaging or histology
Degree of steatosis by imaging or histology, if present
Measured: Assessed at 3, 6, and 12 months post-transplant
Renal dysfunction
Presence of a decrease in GFR > 40 from pre-transplant baseline or creatinine >2 if received simultaneous liver-kidney transplant
Measured: Assessed at 3, 6, and 12 months post-transplant
Hyperlipidemia
Number of participants with evidence of hyperlipidemia
Measured: Assessed at 3, 6, and 12 months post-transplant
Immunosuppression medications
Types of immunosuppression medications required
Measured: Assessed at 3, 6, and 12 months post-transplant
Dosage of immunosuppression medications
Dosage of immunosuppression medications required in respective unit measurement (i.e. milligrams)
Measured: Assessed at 3, 6, and 12 months post-transplant
Drug levels of immunosuppression medications
Drug levels of immunosuppression medications present in blood titers drawn from participant in respective unit measurement (i.e. ng/mL)
Measured: Assessed at 3, 6, and 12 months post-transplant
Re-listing for transplantation
Number of participants who require re-listing for transplantation within 1 year post-op
Measured: Assessed at 3, 6, and 12 months post-transplant
Graft failure
Number of participants with evidence of graft failure
Measured: Assessed at 3, 6, and 12 months post-transplant
Patient death
Number of participants with evidence of patient death
Measured: Assessed at 3, 6, and 12 months post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start28 Feb 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidi Yeh, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088758
- Sponsor's protocol ID
- 2023P002561
- Status last verified
- Oct 2025
- First submitted
- 22 Sep 2023
- Last updated
- 3 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normothermic Machine Perfusion of Steatotic Livers for Expansion of Donor Organ Pool
- ClinicalTrials.gov ID
- NCT06088758
- Acronym / sponsor ID
- 2023P002561
- Conditions
- Liver Transplant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver Transplantation with Steatotic Liver | Experimental | Device: Normothermic machine perfusion (NMP) of steatotic liverGraft will be selected if 30-60% macrosteatosis and transplanted into liver transplant recipient with MELD of 15-25. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80 years
- Listed for liver transplantation at MGH
- Calculated MELD-Na score <= 25
- Able to consent
Key exclusion criteria (5 listed)
- Status 1a
- Cardiac or pulmonary disease
- Prior liver transplant
- Requiring pressors at the time of liver offer
- MELD<15 and asymptomatic from liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normothermic machine perfusion (NMP) of steatotic liverSteatotic liver grafts that are selected will be run on NMP to assess quality of graft and determine whether it meets criteria for transplantation | Device | Liver Transplantation with Steatotic Liver |
Primary outcome
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
29 secondary outcomes
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
Adverse events
Time frame: First 30 days post-transplantation
Biopsy-proven rejection episodes
Time frame: 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
Additional procedures
Time frame: Assessed at 3, 6, and 12 months post-transplant
Re-admissions
Time frame: 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
Vascular complications by cross-sectional imaging or angiography
Time frame: 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
Degree of steatosis by imaging or histology
Time frame: Assessed at 3, 6, and 12 months post-transplant
Renal dysfunction
Time frame: Assessed at 3, 6, and 12 months post-transplant
Hyperlipidemia
Time frame: Assessed at 3, 6, and 12 months post-transplant
Immunosuppression medications
Time frame: Assessed at 3, 6, and 12 months post-transplant
Dosage of immunosuppression medications
Time frame: 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
Re-listing for transplantation
Time frame: Assessed at 3, 6, and 12 months post-transplant
Graft failure
Time frame: Assessed at 3, 6, and 12 months post-transplant
Patient death
Time frame: Assessed at 3, 6, and 12 months post-transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normothermic machine perfusion (NMP) of steatotic liver in people with Liver Transplant, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heidi Yeh, MD (617-643-4533, hyeh@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early allograft dysfunction (time frame: First week after transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025.