Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation

This is a prospective, multi-center, controlled, randomized, pivotal study to evaluate the safety and effectiveness of the VitaSmart™ Liver Machine Perfusion System by comparing clinical outcomes in patients undergoing liver transplantation with ex-vivo liver preservation using static cold storage (SCS) followed by hypothermic oxygenated machine perfusion (HOPE) versus SCS only.

Donation after Brain Death (DBD) Liver Inclusion Criteria (one or more): * Donor age 50-85 years * Anticipated cold ischemia time 10-15 hours (excluding HOPE duration) * Macrosteatosis 10-40% * Terminal ALT 250-1500 IU/ml * Peak ALT within 3 days 1000-3000 IU/ml * Terminal total bilirubin 2-4 mg/dl Donation after Brain Death (DBD) Liver Exclusion Criteria (one or more): * Donor age \85 years * Anticipated cold ischemia \>15 hours * Macrosteatosis \>40% * Terminal ALT \>1500 IU/ml * Peak ALT within 3 days \>3000 IU/ml * Terminal total bilirubin \>4 mg/dl * Presence of hemodynamic and/or anatomical donor abnormalities that, in the opinion of the Investigator, make the liver allograft unsuitable for transplant into the recipient subject * Liver intended for split transplant * Liver from living donor * Donor terminal serum Na \>160 mmol/L Donation after Cardio-circulatory Death (DCD) Liver Inclusion Criteria (all): * Donor age 18-60 years * Anticipated cold ischemia time \