Liver Preservation
Conditions
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.
Interventions
DEVICEOCS Liver
OCS Liver will be used to preserve the donor liver
Sponsors
TransMedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of donor livers maintained in a metabolically active and functioning state during preservation. | Within 1 day of organ retrieval |
| 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 |
| Frequency of liver graft-related serious adverse events | 30 days after transplantation |
Countries
United Kingdom
Outcome results
None listed