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

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

Completed

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Key information

Conditions

Liver Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Memorial Hospital, Chicago, Illinois, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypothermic machine perfusion

Device

Organ Recovery Systems LifePort® Liver Transporter (LLT) System and Vasosol® Machine Perfusion Solution

Static cold storage

Device

Static cold storage (standard of care)

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Organ Recovery Systems, Inc.

Industry

Registry information

Official study 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)

Acronym: PILOT™

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: Mar 30, 2018
Registry last updated: Oct 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed