OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation
Purpose
A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness of the OCS™ Liver to preserve and assess donor livers intended for transplantation.
Conditions
- Liver Transplantation
- Liver Preservation for Transplant
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental OCS Liver System |
OCS Liver System |
|
|
Other Control |
Standard of care (ice) |
|
More Details
- Status
- Completed
- Sponsor
- TransMedics
Study Contact
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.