OCS Liver PROTECT Continued Access Protocol
- Conditions
- Liver Transplant
- Interventions
- Device: OCS Liver System
- Registration Number
- NCT04186221
- Lead Sponsor
- TransMedics
- Brief Summary
Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.
- Detailed Description
A prospective, single arm, continued access protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers having one or more of the following characteristics:
1. Donor age equal to or greater than 40 years old, or
2. Expected cross clamp time of 6 hours or greater, or
3. Donor after circulatory death (DCD) with age less than or equal to 55 years; or
4. Steatotic lever \>0% and less than or equal to 40% at time of retrieval, based on pre-retrieval histology)
A maximum of 21 sites will enroll up to 184 transplanted liver recipients. The primary effectiveness endpoint will be the incidence of Early Allograft Dysfunction (EAD) or primary non-function.
All recipients will be followed for 24 months from the date of transplantation (some of which will be post-market).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment arm OCS Liver System -
- Primary Outcome Measures
Name Time Method 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 post transplantation.
Trial Locations
- Locations (17)
Tampa General
🇺🇸Tampa, Florida, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
University of Texas Southwest
🇺🇸Dallas, Texas, United States
UCSF
🇺🇸San Francisco, California, United States
University of California San Diego
🇺🇸La Jolla, California, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Methodist University Hospital
🇺🇸Memphis, Tennessee, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Scripps
🇺🇸La Jolla, California, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Montefiore Einstein Center for Transplantation
🇺🇸Bronx, New York, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Virginia Commonwealth University Health System
🇺🇸Richmond, Virginia, United States
The University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States