OCS Liver DCD Trial
Purpose
Evaluate the safety and effectiveness of the OCS Liver System to preserve, optimize the condition, and assess levers from DCD donors.
Condition
- Liver Transplant
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Registered primary liver transplant candidate - Age ≥ 18 years - Obtained informed consent
Exclusion Criteria
- Acute, fulminant liver failure - Prior solid organ or bone marrow transplant - Ventilator dependent on day of transplant/donor organ offer
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental OCS Preserved Livers |
This is a single-arm trial of OCS preserved livers used for transplantation. |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- TransMedics
Study Contact
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.