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Purpose

A multicenter randomized controlled trial to compare the efficacy of ex-vivo normothermic machine profusion with static cold storage in human liver transplantation.

Condition

Eligibility

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

Inclusion Criteria

  • Subject is 18 years of age or greater - Subject is registered as an active recipient on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation - Subject, or legally authorized representative, is able and willing to give informed consent and HIPAA authorization - Subject is able and willing to comply with all study requirements

Exclusion Criteria

  • Subject requiring all of the following at the time of transplantation: oxygen therapy, inotropic support, renal replacement therapy - Subject has acute/fulminant liver failure - Subject undergoing simultaneous transplantation of more than one organ - Subject is pregnant or nursing - Concurrent enrollment in another clinical trial. Subjects enrolled in clinical trials or registries where only measurements and/or samples are taken (NO TEST DEVICE or TEST DRUG USED) are allowed to participate.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Normothermic Machine Perfusion (NMP) 		Following the routine retrieval procedure of the liver, it will be placed on the OrganOx metra for Normothermic Machine Perfusion (NMP) for transport per the Investigational Plan and the Instructions For Use.
  • Device: Normothermic Machine Perfusion (NMP)
    Other names:
    • OrganOx metra® device
Other
Standard of Care (Ice) 		Following the routine retrieval procedure of the liver, it will be placed in ice-cold perfusion solution within an ice box for transport as dictated by logistics and local policy.
  • Other: Standard of Care (Ice)

More Details

Status
Completed
Sponsor
OrganOx Ltd.

Study Contact

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.