OCS Liver DCD Trial
- Conditions
- Liver Transplant
- Registration Number
- NCT04194437
- Lead Sponsor
- TransMedics
- Brief Summary
Evaluate the safety and effectiveness of the OCS Liver System to preserve, optimize the condition, and assess levers from DCD donors.
- Detailed Description
To evaluate the safety and effectiveness of the OCS™ Liver to preserve, optimize the condition and assess livers from DCD donors that currently are seldom used for liver transplants due to limitations of cold static storage with extended warm ischemic time and older donors.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
- Registered primary liver transplant candidate
- Age ≥ 18 years
- Obtained informed consent
- Acute, fulminant liver failure
- Prior solid organ or bone marrow transplant
- Ventilator dependent on day of transplant/donor organ offer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Liver Graft Survival Through 6 Months Post-transplant 6 months Evaluation of graft survival as defined per UNOS data collection criteria for graft status after liver transplantation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Scripps
🇺🇸La Jolla, California, United States
University of San Diego
🇺🇸La Jolla, California, United States
UCSF
🇺🇸San Francisco, California, United States
Stanford University
🇺🇸Stanford, California, United States
Tampa General
🇺🇸Tampa, Florida, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Montefiore
🇺🇸Bronx, New York, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Scroll for more (4 remaining)Scripps🇺🇸La Jolla, California, United States