To provide continued access for the LLT system to provide additional safety data in support of the PILOT pivotal efficacy and safety trial
To provide continued access for the LLT System with Vasosol® for the preservation of whole explanted livers, thereby providing additional safety data in support of the PILOT pivotal efficacy and safety trial
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
385
Organ Recovery Systems LifePort® Liver Transporter (LLT) System and Vasosol® Machine Perfusion Solution
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
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Intermountain Medical Center
Murray, Utah, United States