Trial of the TransMedics Organ Care System™ Liver For Preserving and Assessing Donor Livers for Transplantation (REVIVE)

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

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 Overview

• Status: Completed
• Conditions: Liver Preservation
• Intervention / Treatment: Device: OCS Liver

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS9 7 TF
      • St. James's University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OCS Liver; OCS Liver will be used to preserve the donor liver	Device: OCS Liver; OCS Liver will be used to preserve the donor liver

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: TransMedics

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): September 19, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: May 11, 2015
• First Submitted That Met QC Criteria: May 15, 2015
• First Posted (Estimate): May 20, 2015

Study Record Updates

• Last Update Posted (Actual): April 6, 2018
• Last Update Submitted That Met QC Criteria: April 4, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: OCS-LVR-022015