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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03484455
Recruitment Status : Completed
First Posted : March 30, 2018
Last Update Posted : October 7, 2022
Sponsor:
Information provided by (Responsible Party):
Organ Recovery Systems, Inc.

Study Description
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Brief Summary:
Comparison of hypothermic machine perfusion of livers to standard of care (static cold storage).

Condition or disease Intervention/treatment Phase
Liver Transplantation Device: Hypothermic machine perfusion Device: Static cold storage Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : April 3, 2019
Actual Primary Completion Date : July 12, 2022
Actual Study Completion Date : July 12, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients in each arm with Early Allograft Dysfunction (EAD) [ Time Frame: 7 days ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484455


Locations
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United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, New Jersey
Rutgers New Jersey Medical School
Newark, New Jersey, United States, 07101
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Columbia University Medical Center
New York, New York, United States, 10032
University of Rochester Strong Memorial Hospital
Rochester, New York, United States, 14642
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84107
United States, Virginia
University of Virginia Hospital
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
Organ Recovery Systems, Inc.
Investigators
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Study Director: Stan Harris Organ Recovery Systems
Study Chair: Matthew Copithorne Organ Recovery Systems
More Information
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Responsible Party: Organ Recovery Systems, Inc.
ClinicalTrials.gov Identifier: NCT03484455    
Other Study ID Numbers: 2017-US-01-ORS
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: October 7, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes