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

Organ Recovery Systems

Status: Completed

Conditions: Liver Transplantation

Treatments: Device: Static cold storage; Device: Hypothermic machine perfusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT03484455

2017-US-01-ORS

Details and patient eligibility

About

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

Full 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.

Enrollment: 142 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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142 participants in 2 patient groups

Hypothermic Machine Perfusion

Experimental group

Description:

Hypothermic Machine Perfusion with Organ Recovery Systems LLT system

Treatment:

Device: Hypothermic machine perfusion

Static Cold Storage

Active Comparator group

Description:

Standard of Care - Static Cold Storage

Treatment:

Device: Static cold storage