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

Not Applicable

Completed

• Conditions: Liver Transplantation
• Interventions: Device: Hypothermic machine perfusion; Device: Static cold storage

• Registration Number: NCT03484455
• Lead Sponsor: Organ Recovery Systems, Inc.

Brief Summary

Comparison of hypothermic machine perfusion of livers to standard of care (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 Timeline

• Study First Submitted: 2018-03-02
• Study First Submitted QC: 2018-03-29
• Study First Posted: 2018-03-30
• Study Start: 2019-04-03
• Primary Completion: 2022-07-12
• Study Completion: 2022-07-12
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-06
• Last Update Posted: 2022-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypothermic Machine Perfusion	Hypothermic machine perfusion	Hypothermic Machine Perfusion with Organ Recovery Systems LLT system
Static Cold Storage	Static cold storage	Standard of Care - Static Cold Storage

Primary Outcome Measures

Name	Time	Method
Number of patients in each arm with Early Allograft Dysfunction (EAD)	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

Trial Locations

Locations (9)

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States

University of Virginia Hospital; 🇺🇸 Charlottesville, Virginia, United States

University of Rochester Strong Memorial Hospital; 🇺🇸 Rochester, New York, United States

Rutgers New Jersey Medical School; 🇺🇸 Newark, New Jersey, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States