Clinical Research Directory

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 \<18 or \>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 \<12 hours (excluding HOPE duration) * Functional warm ischemia time ≤35 minutes, defined as interval from the time of onset of donor hypotension (MAP \<50mmHg) until the time of donor cross clamp * Macrosteatosis ≤20% * Terminal ALT ≤500 IU/ml * Peak ALT within 3 days ≤2000 IU/ml * Terminal total bilirubin ≤3 mg/dl Donation after Cardio-circulatory Death (DCD) Liver Exclusion Criteria (one or more): * 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 Recipient Inclusion Criteria (one or more): * Subject (or legally authorized representative) is able to provide informed consent and HIPAA authorization * Subject is male or female and at least 18 years of age * Subject is registered as an active liver recipient on the UNOS waiting list for liver transplantation * Subject will undergo primary liver transplantation * Subject is willing to comply with the study requirements and procedures * Subject with hepatocellular carcinoma as indication for Orthotopic Liver Transplantation; the tumor must be within Milan Criteria or down-staged to Milan Criteria Recipient Exclusion Criteria (one or more): * Subject will undergo multiple organ transplantations (liver-kidney, liver-lung, etc.) * Subject is listed for liver transplantation due to fulminant liver failure (UNOS status 1A) * Subject is pregnant * Subject is on respiratory (ventilator dependent) and/or cardiocirculatory support (requires at least one intravenous inotrope to maintain hemodynamics) * Subject is enrolled in an interventional clinical trial with an investigational drug or device