Study to Evaluate Performance of the Organ Recovery Systems LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant (PILOT™)

A Prospective Randomized Multi-Center Study of the Use of the Organ Recovery Systems LifePort® Liver Transporter (LLT) System With Vasosol® as Compared to Static Cold Storage in Orthotopic Liver Transplants (Perfusion to Improve Liver Outcomes in Transplantation)

Comparison of hypothermic machine perfusion of livers to standard of care (static cold storage).

Study Overview

• Status: Completed
• Conditions: Liver Transplantation
• Intervention / Treatment: Device: Hypothermic machine perfusion; Device: Static cold storage

Detailed Description

Prospective, randomized, multi-center study to show safe and effective use of whole liver preservation via hypothermic machine perfusion (HMP) as compared to livers preserved by static cold storage.

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
  • New Jersey
    • Newark, New Jersey, United States, 07101
      • Rutgers New Jersey Medical School
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • Rochester, New York, United States, 14642
      • University of Rochester Strong Memorial Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati Medical Center
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia 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:

• ≥18 years of age
• Active on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation
• De novo liver transplant recipient
• Written informed consent required

Exclusion Criteria:

• Subject is a multi-organ transplant recipient
• Subject is antibodies blood group (ABO) liver incompatible
• Subject has severe systemic infection
• Subject is Human Immunodeficiency Virus (HIV) positive
• Subject has acute/fulminant liver failure
• Subject is pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypothermic Machine Perfusion; Hypothermic Machine Perfusion with Organ Recovery Systems LLT system	Device: Hypothermic machine perfusion; Organ Recovery Systems LifePort® Liver Transporter (LLT) System and Vasosol® Machine Perfusion Solution
Active Comparator: Static Cold Storage; Standard of Care - Static Cold Storage	Device: Static cold storage; Static cold storage (standard of care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients in each arm with Early Allograft Dysfunction (EAD)	EAD defined as total bilirubin ≥ 10 mg/dL or International Normalized Ratio (INR) ≥ 1.6 or Aspartate Aminotransferase (AST) >2000IU/L or Alanine Aminotransferase (ALT) > 2000 IU/L	7 days

Collaborators and Investigators

• Sponsor: Organ Recovery Systems, Inc.
• Investigators: Study Director: Stan Harris, Organ Recovery Systems; Study Chair: Matthew Copithorne, Organ Recovery Systems

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2019
• Primary Completion (Actual): July 12, 2022
• Study Completion (Actual): July 12, 2022

Study Registration Dates

• First Submitted: March 2, 2018
• First Submitted That Met QC Criteria: March 29, 2018
• First Posted (Actual): March 30, 2018

Study Record Updates

• Last Update Posted (Actual): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2017-US-01-ORS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes