WP01 - Normothermic Liver Preservation

A Multicenter Randomized Controlled Trial to Compare the Efficacy of Ex-vivo Normothermic Machine Perfusion With Static Cold Storage in Human Liver Transplantation

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

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.