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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Steatotic liver grafts that are selected will be run on NMP to assess quality of graft and determine whether it meets criteria for transplantation
Massachusetts General Brigham
Boston, Massachusetts, United States
RECRUITINGEarly 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
Time frame: First week after transplant
Intraoperative inotropic support
Number of participants in need of inotropic support to maintain hemodynamics intraoperatively after reperfusion of liver allograft
Time frame: 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
Time frame: First 30 days post-transplantation
Length of post-operative inotropic support
Length of inotropic support used after admission to the ICU, if needed
Time frame: First 30 days post-transplantation
Need for post-operative mechanical ventilation
Number of participants in need of mechanical ventilation upon admission to ICU
Time frame: First 30 days post-transplantation
Length of post-operative mechanical ventilation
Length of intubation after admission to ICU, if mechanical ventilation needed
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Time frame: First 30 days post-transplantation
ICU length of stay
Length of stay in ICU post-transplant
Time frame: 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
Time frame: First 30 days post-transplantation
Peak AST and ALT
Concentration of peak AST and ALT
Time frame: First 7 days post-transplantation
Internal Normalized Ratio (INR)
INR measurements for each participant until post-op day 7 or discharge
Time frame: 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
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
30-day patient survival (percentage)
Time frame: First 30 days post-transplantation
Re-listing for transplantation
Number of participants who require re-listing for liver transplantation within 30 days post-op
Time frame: 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
Time frame: First 30 days post-transplantation
Biopsy-proven rejection episodes
Number of participants with biopsy-proven rejection episodes
Time frame: 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
Time frame: 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
Time frame: Assessed at 3, 6, and 12 months post-transplant
Re-admissions
Number of participants with re-admissions after initial discharge
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Assessed at 3, 6, and 12 months post-transplant
Hyperlipidemia
Number of participants with evidence of hyperlipidemia
Time frame: Assessed at 3, 6, and 12 months post-transplant
Immunosuppression medications
Types of immunosuppression medications required
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Assessed at 3, 6, and 12 months post-transplant
Graft failure
Number of participants with evidence of graft failure
Time frame: Assessed at 3, 6, and 12 months post-transplant
Patient death
Number of participants with evidence of patient death
Time frame: Assessed at 3, 6, and 12 months post-transplant