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

TransMedics1 site in 1 country25 target enrollmentMay 2016

ConditionsLiver Preservation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Liver Preservation
Sponsor: TransMedics
Enrollment: 25
Locations: 1
Primary Endpoint: Number of donor livers preserved by OCS in a near physiologic state.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

May 2016

End Date

January 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

TransMedics

Responsible Party

Sponsor

Eligibility Criteria

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.

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)