WP01 - Normothermic Liver Preservation

OrganOx

Status: Completed

Conditions: Liver Transplantation

Treatments: Other: Standard of Care (Ice); Device: Normothermic Machine Perfusion (NMP)

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT02775162

WP01

Details and patient eligibility

About

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

Enrollment: 267 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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267 participants in 2 patient groups

Normothermic Machine Perfusion (NMP)

Experimental group

Description:

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.

Treatment:

Device: Normothermic Machine Perfusion (NMP)

Standard of Care (Ice)

Other group

Description:

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.

Treatment:

Other: Standard of Care (Ice)