Liver Transplantation
Conditions
Brief summary
Comparison of hypothermic machine perfusion of livers to standard of care (static cold storage).
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.
Interventions
Organ Recovery Systems LifePort® Liver Transporter (LLT) System and Vasosol® Machine Perfusion Solution
DEVICEStatic cold storage
Static cold storage (standard of care)
Sponsors
Organ Recovery Systems, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients in each arm with Early Allograft Dysfunction (EAD) | 7 days | EAD defined as total bilirubin ≥ 10 mg/dL or International Normalized Ratio (INR) ≥ 1.6 or Aspartate Aminotransferase (AST) \>2000IU/L or Alanine Aminotransferase (ALT) \> 2000 IU/L |
Countries
United States
Outcome results
None listed