Comparison of hypothermic machine perfusion of livers to standard of care (static cold storage).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
142
Organ Recovery Systems LifePort® Liver Transporter (LLT) System and Vasosol® Machine Perfusion Solution
Static cold storage (standard of care)
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
Number of patients in each arm with Early Allograft Dysfunction (EAD)
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
Time frame: 7 days
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Columbia University Medical Center
New York, New York, United States
University of Rochester Strong Memorial Hospital
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Intermountain Medical Center
Murray, Utah, United States
University of Virginia Hospital
Charlottesville, Virginia, United States