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NCT03484455 Clinical Trial

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

Liver Transplantation Clinical Trial

— PILOT™  

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03484455
Other study ID # 2017-US-01-ORS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 3, 2019
Est. completion date July 12, 2022

Study information
Verified date October 2022
Source Organ Recovery Systems, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 142
Est. completion date July 12, 2022
Est. primary completion date July 12, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Hypothermic machine perfusion
Organ Recovery Systems LifePort® Liver Transporter (LLT) System and Vasosol® Machine Perfusion Solution
• Static cold storage
Static cold storage (standard of care)

Locations
Country Name City State
United States Montefiore Medical Center Bronx New York
United States University of Virginia Hospital Charlottesville Virginia
United States Northwestern Memorial Hospital Chicago Illinois
United States University of Chicago Medical Center Chicago Illinois
United States University of Cincinnati Medical Center Cincinnati Ohio
United States Intermountain Medical Center Murray Utah
United States Columbia University Medical Center New York New York
United States Rutgers New Jersey Medical School Newark New Jersey
United States University of Rochester Strong Memorial Hospital Rochester New York

Sponsors (1)
Lead Sponsor Collaborator
Organ Recovery Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
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