Purpose

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

Condition

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 LLT system
  • Device: Hypothermic machine perfusion
    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)

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467
Contact:
Juan P. Rocca, MD

More Details

NCT ID
NCT03484455
Status
Recruiting
Sponsor
Organ Recovery Systems, Inc.

Study Contact

Matthew Copithorne
847-824-2421
mcopithorne@organ-recovery.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.