WP01 - Normothermic Liver Preservation
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
- Liver Transplantation
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
Arm | Description | Assigned 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. |
|
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. |
|
More Details
- Status
- Completed
- Sponsor
- OrganOx Ltd.