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)
1 other identifier
interventional
142
1 country
9
Brief Summary
Comparison of hypothermic machine perfusion of livers to standard of care (static cold storage).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2019
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2018
CompletedFirst Posted
Study publicly available on registry
March 30, 2018
CompletedStudy Start
First participant enrolled
April 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2022
CompletedOctober 7, 2022
October 1, 2022
3.3 years
March 2, 2018
October 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Hypothermic Machine Perfusion
EXPERIMENTALHypothermic Machine Perfusion with Organ Recovery Systems LLT system
Static Cold Storage
ACTIVE COMPARATORStandard of Care - Static Cold Storage
Interventions
Organ Recovery Systems LifePort® Liver Transporter (LLT) System and Vasosol® Machine Perfusion Solution
Eligibility Criteria
You may qualify if:
- ≥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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07101, United States
Columbia University Medical Center
New York, New York, 10032, United States
University of Rochester Strong Memorial Hospital
Rochester, New York, 14642, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
University of Virginia Hospital
Charlottesville, Virginia, 22903, United States
Study Officials
- STUDY DIRECTOR
Stan Harris
Organ Recovery Systems
- STUDY CHAIR
Matthew Copithorne
Organ Recovery Systems
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2018
First Posted
March 30, 2018
Study Start
April 3, 2019
Primary Completion
July 12, 2022
Study Completion
July 12, 2022
Last Updated
October 7, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share