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

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

Number of participants in need of inotropic support to maintain hemodynamics intraoperatively after reperfusion of liver allograft

Number of participants in need of inotropic support upon admission to the ICU

Length of inotropic support used after admission to the ICU, if needed

Number of participants in need of mechanical ventilation upon admission to ICU

Length of intubation after admission to ICU, if mechanical ventilation needed

Length of stay in ICU post-transplant

Number of participants who require renal replacement therapy during the first 10 days after liver transplantation, if not on renal replacement prior to transplant

Concentration of peak AST and ALT

INR measurements for each participant until post-op day 7 or discharge

Total bilirubin measurement (mg/dl) on post-op day 7 or day of discharge

30-day patient survival (percentage)

Number of participants who require re-listing for liver transplantation within 30 days post-op

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

Number of participants with biopsy-proven rejection episodes

Number of participants with liver function tests more than 3 times normal; liver function tests (LFTs) will measure AST/ALT, bilirubin, INR

Number of participants that require additional procedures beyond normal recovery standard of care post-liver transplant

Number of participants with re-admissions after initial discharge

Number of participants with evidence of ischemic cholangiopathy and anastomotic strictures by imaging

Number of participants with evidence of vascular complications by cross-sectional imaging or angiography

Number of participants with evidence of steatosis by imaging or histology

Degree of steatosis by imaging or histology, if present

Presence of a decrease in GFR > 40 from pre-transplant baseline or creatinine >2 if received simultaneous liver-kidney transplant

Number of participants with evidence of hyperlipidemia

Types of immunosuppression medications required

Dosage of immunosuppression medications required in respective unit measurement (i.e. milligrams)

Drug levels of immunosuppression medications present in blood titers drawn from participant in respective unit measurement (i.e. ng/mL)

Number of participants who require re-listing for transplantation within 1 year post-op

Number of participants with evidence of graft failure

Number of participants with evidence of patient death