Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation
Study Phase: N/A
Recruitment Status: Recruiting
Start Date: December 16, 2021
End Date: November 30, 2024
- 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
-
Conditions:
- Liver Diseases
- Liver Failure
- End Stage Liver Disease