Trial of the TransMedics Organ Care System™ Liver For Preserving and Assessing Donor Livers for Transplantation
Not Applicable
Completed
- Conditions
- Liver Preservation
- Interventions
- Device: OCS Liver
- Registration Number
- NCT02449694
- Lead Sponsor
- TransMedics
- Brief Summary
A prospective, single-center controlled trial to evaluate the safety and performance of the portable Organ Care System (OCS) Liver for preservation and assessment of donor livers for transplantation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
- Registered male or female primary Liver transplant candidate
- Age ≥18 years old
- Signed: written informed consent
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 (>265 mmol/L) for >2 weeks and/or requiring hemodialysis;
- Multi-organ transplant;
- Ventilator dependent;
- Dependent on > 1 IV inotrope to maintain hemodynamics;
- Malignancy excluding HCC;
- Infection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description OCS Liver OCS Liver OCS Liver will be used to preserve the donor liver
- Primary Outcome Measures
Name Time Method Number of donor livers preserved by OCS in a near physiologic state. Within 1 day of organ retrieval Number of events directly related to the use of the OCS Liver that led to the donor liver being deemed not clinically acceptable and, as a result, not transplanted Within 1 day of organ retrieval
- Secondary Outcome Measures
Name Time Method Number of donor livers monitored for perfusate temperatures, SvO2, hematocrit, Hepatic Artery flow rates, Portal Vein flow rate, Hepatic Artery pressure, Portal vein pressure, and bile production during preservation. Within 1 day of organ retrieval Number of donor livers maintained in a metabolically active and functioning state during preservation. Within 1 day of organ retrieval Frequency of liver graft-related serious adverse events 30 days after transplantation
Trial Locations
- Locations (1)
St. James's University Hospital
🇬🇧Leeds, West Yorkshire, United Kingdom