Study to Evaluate Performance of LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant
Purpose
Comparison of hypothermic machine perfusion of livers to standard of care (static cold storage).
Condition
- Liver Transplantation
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Hypothermic Machine Perfusion |
Hypothermic Machine Perfusion with LLT system |
|
|
Active Comparator Static Cold Storage |
Standard of Care - Static Cold Storage |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Organ Recovery Systems, Inc.
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.