OCS Liver PROTECT Continued Access Protocol
Purpose
Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.
Condition
- Liver Transplant
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
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 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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Prospective, single-arm, continued access protocol
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment arm |
|
More Details
- Status
- Completed
- Sponsor
- TransMedics
Study Contact
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).