OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation

Not Applicable

Completed

Brief Summary: A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness of the OCS™ Liver to preserve and assess donor livers intended for transplantation.

Detailed Description: The OCS™ Liver PROTECT Trial is a two-armed, multicenter, prospective, randomized, controlled pivotal trial to evaluate the effectiveness and safety of the OCS Liver to preserve and assess donor livers intended for transplantation.

Recruitment & Eligibility

Inclusion Criteria

Registered male or female primary Liver transplant candidate
Age ≥18 years old
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

Arm && Interventions

Group	Intervention	Description
OCS Liver System	OCS™ Liver System	OCS Liver System
Control	Control	Standard of care (ice)

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint: Liver Graft-related Serious Adverse Events (LGRSAEs) up to 30-days Post-transplant Per Patient	30 days	Defined as the average number of LGRSAEs (Liver Graft-Related Serious Adverse Event) up to the 30-day follow-up after transplantation per patient.
Participants With Early Liver Allograft Dysfunction (EAD)	7 days	Participants with Early liver Allograft Dysfunction (EAD) or primary non-function, defined as presence of one or more of the following criteria: AST level \> 2000 IU/ml within the first 7 postoperative days; Bilirubin ≥ 10 mg/dl on postoperative day 7; INR ≥ 1.6 on postoperative day 7; or Primary non-functioning graft within the first 7 days (defined as irreversible graft dysfunction requiring emergency liver re-transplantation or death, in the absence of immunologic or surgical causes)

Secondary Outcome Measures

Name	Time	Method
Patient Survival at Day 30 After Transplant	30 days after transplant	Patient survival at day 30 after transplantation
Patient Survival at Initial Hospital Discharge Post Liver Transplant	at initial hospital discharge post liver transplant, an average of 11 days	Patient survival at initial hospital discharge post liver transplantation

Locations (20): Johns Hopkins
🇺🇸
Baltimore, Maryland, United States
Scripps
🇺🇸
San Diego, California, United States
Emory
🇺🇸
Atlanta, Georgia, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
University of Washington
🇺🇸
Seattle, Washington, United States
University of Minnesota
🇺🇸
Minneapolis, Minnesota, United States
University of Texas Southwest
🇺🇸
Dallas, Texas, United States
University of Texas San Antonio
🇺🇸
San Antonio, Texas, United States
University of California San Diego
🇺🇸
La Jolla, California, United States
Tampa General
🇺🇸
Tampa, Florida, United States
University of California San Francisco
🇺🇸
San Francisco, California, United States
Henry Ford Hospital
🇺🇸
Detroit, Michigan, United States
University of Nebraska Medical Center
🇺🇸
Omaha, Nebraska, United States
Montefiore Einstein Center for Transplantation
🇺🇸
Bronx, New York, United States
Mount Sinai
🇺🇸
New York, New York, United States
Ohio State University Medical Center
🇺🇸
Columbus, Ohio, United States
Methodist University Hospital
🇺🇸
Memphis, Tennessee, United States
Houston Methodist
🇺🇸
Houston, Texas, United States
University of Virginia
🇺🇸
Charlottesville, Virginia, United States
Virginia Commonwealth University
🇺🇸
Richmond, Virginia, United States