OCS Liver PROTECT Continued Access Protocol

Recipient Inclusion Criteria: * Registered primary liver transplant candidate, male or female * Age ≥ 18 years * Signed (1) written informed consent document and (2) authorization to use and disclose protected health information Exclusion Criteria: * Acute, fulminant liver failure * Prior solid organ or bone marrow transplant * Chronic use of hemodialysis or diagnosis of chronic renal failure, defined as chronic serum creatinine of \> 3 mg/dl for \> 2 weeks and/or requiring hemodialysis * Multi-organ transplant * Ventilator dependent * Dependent on \> 1 IV inotrope to maintain hemodynamics Donor Inclusion Criteria * Donor age ≥ 40 years, or * Expected cross-clamp time ≥ 6 hours, or * Donor after circulatory death (DCD) with age ≤ 55 years, or * Steatotic liver \> 0% and ≤ 40% macrosteatosis at time of retrieval Donor Exclusion Criteria * Living donors * Liver intended for split transplants * Positive serology (HIV, Hepatitis B surface antigen \& Hepatitis C) * Presence of moderate or severe traumatic liver injury, or anatomical liver abnormalities that would compromise ex-vivo perfusion of the donor liver (i.e., accessory blood vessels or other anatomy that require surgical repair) and livers with active bleeding (e.g., hematomas) * Donor livers with macrosteatosis of \> 40% based on retrieval biopsy readout.