NCT02449694CompletedNot Applicable
Single-arm Prospective Trial to Evaluate The Safety and Performance of The Portable Organ Care System (OCS™) Liver For Preserving and Assessing Donor Livers for Transplantation
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- TransMedics
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Number of donor livers preserved by OCS in a near physiologic state.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
OCS Liver
Experimental
OCS Liver will be used to preserve the donor liver
Intervention: OCS Liver (Device)
Outcomes
Primary Outcomes
Number of donor livers preserved by OCS in a near physiologic state.
Time Frame: 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
Time Frame: Within 1 day of organ retrieval
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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