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

Purpose

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

Condition

  • Liver Transplantation

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Hypothermic Machine Perfusion 		Hypothermic Machine Perfusion with Organ Recovery Systems LLT system
  • Device: Hypothermic machine perfusion
    Organ Recovery Systems LifePort® Liver Transporter (LLT) System and Vasosol® Machine Perfusion Solution
Active Comparator
Static Cold Storage 		Standard of Care - Static Cold Storage
  • Device: Static cold storage
    Static cold storage (standard of care)

More Details

Status
Completed
Sponsor
Organ Recovery Systems, Inc.

Study Contact

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.