Clinical trial NCT06088758: Normothermic Machine Perfusion of Steatotic Livers for Expansion of Donor Organ Pool
Official title: Normothermic Machine Perfusion of Steatotic Livers for Expansion of Donor Organ Pool
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Transplant
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.


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

Primary outcomes:
measure: Early allograft dysfunction
timeFrame: First week after transplant
Secondary outcomes:
measure: Intraoperative inotropic support
timeFrame: At reperfusion, 15 minutes, 1 hour, 2 hours, and 3 hours after reperfusion
measure: Need for post-operative inotropic support
timeFrame: First 30 days post-transplantation
measure: Length of post-operative inotropic support
timeFrame: First 30 days post-transplantation
measure: Need for post-operative mechanical ventilation
timeFrame: First 30 days post-transplantation
measure: Length of post-operative mechanical ventilation
timeFrame: First 30 days post-transplantation
measure: ICU length of stay
timeFrame: First 30 days post-transplantation
measure: Renal replacement therapy requirement
timeFrame: First 30 days post-transplantation
measure: Peak AST and ALT
timeFrame: First 7 days post-transplantation
measure: Internal Normalized Ratio (INR)
timeFrame: First 7 days post-transplantation or within first 30 days post-op if discharge is longer than 7 days out
measure: Total bilirubin
timeFrame: First 7 days post-transplantation or within first 30 days post-op if discharge is longer than 7 days out
measure: 30-day patient survival
timeFrame: First 30 days post-transplantation
measure: Re-listing for transplantation
timeFrame: First 30 days post-transplantation
measure: Adverse events
timeFrame: First 30 days post-transplantation
measure: Biopsy-proven rejection episodes
timeFrame: Assessed at 3, 6, and 12 months post-transplant
measure: Liver function tests more than 3 times normal
timeFrame: Assessed at 3, 6, and 12 months post-transplant
measure: Additional procedures
timeFrame: Assessed at 3, 6, and 12 months post-transplant
measure: Re-admissions
timeFrame: Assessed at 3, 6, and 12 months post-transplant
measure: Ischemic cholangiopathy and anastomotic strictures by imaging
timeFrame: Assessed at 3, 6, and 12 months post-transplant
measure: Vascular complications by cross-sectional imaging or angiography
timeFrame: Assessed at 3, 6, and 12 months post-transplant
measure: Presence of steatosis by imaging or histology
timeFrame: Assessed at 3, 6, and 12 months post-transplant
measure: Degree of steatosis by imaging or histology
timeFrame: Assessed at 3, 6, and 12 months post-transplant
measure: Renal dysfunction
timeFrame: Assessed at 3, 6, and 12 months post-transplant
measure: Hyperlipidemia
timeFrame: Assessed at 3, 6, and 12 months post-transplant
measure: Immunosuppression medications
timeFrame: Assessed at 3, 6, and 12 months post-transplant
measure: Dosage of immunosuppression medications
timeFrame: Assessed at 3, 6, and 12 months post-transplant
measure: Drug levels of immunosuppression medications
timeFrame: Assessed at 3, 6, and 12 months post-transplant
measure: Re-listing for transplantation
timeFrame: Assessed at 3, 6, and 12 months post-transplant
measure: Graft failure
timeFrame: Assessed at 3, 6, and 12 months post-transplant
measure: Patient death
timeFrame: Assessed at 3, 6, and 12 months post-transplant
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Brigham
state: Massachusetts
Study officials:
References: