A multicenter randomized controlled trial to compare the efficacy of ex-vivo normothermic machine profusion with static cold storage in human liver transplantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
267
University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic - Phoenix
Phoenix, Arizona, United States
Percentage of Participants With Early Allograft Dysfunction (EAD)
EAD is a binary outcome defined by the presence of one of the following 3 outcomes: * Serum bilirubin ≥ 10 mg/dL at day 7 post-transplant * International normalized ratio (INR) ≥ 1.6 at day 7 post-transplant * Alanine Aminotransferase (ALT) or Aspartate Transaminase (AST) \> 2000 IU/L within the first 7 days post-transplant
Time frame: 7 Days
Number of Participants With Primary Non-Function
Primary Non-Function is defined in this study as irreversible graft dysfunction requiring emergency liver replacement during the first 10 days after liver transplantation.
Time frame: 10 Days
Number of Participants With Graft Survival
Time frame: 6 Months
Number of Participants With Subject Survival
Time frame: 6 Months
Number of Participants With Post-Reperfusion Syndrome
Post-Reperfusion Syndrome is defined in this study as a decrease in mean arterial pressure (MAP) of more than 30% from the baseline value for more than one minute during the first five minutes after reperfusion.
Time frame: 1 Day
Measure Biochemical Liver Function Via Bilirubin
Time frame: 6 Months
Measure Biochemical Liver Function Via Gamma-Glutamyl Transferase (GGT)
Time frame: 6 Months
Measure Biochemical Liver Function Via Alanine Aminotransferase (ALT)
Time frame: 6 Months
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University of Southern California (USC)
Los Angeles, California, United States
University of California - Los Angeles (UCLA)
Los Angeles, California, United States
University of California-San Francisco (UCSF)
San Francisco, California, United States
University of Miami
Miami, Florida, United States
Indiana University
Indianapolis, Indiana, United States
Ochsner
New Orleans, Louisiana, United States
University of Maryland
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
...and 5 more locations
Measure Biochemical Liver Function Via Aspartate Transaminase (AST)
Time frame: 6 Months
Measure Biochemical Liver Function Via Alkaline Phosphatase (ALP)
Time frame: 6 Months
Measure Biochemical Liver Function Via International Normalized Ratio (INR)
The international normalized ratio (INR) is a laboratory measurement of how long it takes blood to form a clot. It is calculated using the following formula: INR = (PT \[test\] / PT \[control\])\^ISI INR = international normalized ratio PT \[test\] = tested prothrombin time PT \[control\] = control prothrombin time ISI = international sensitivity index
Time frame: 6 Months
Measure Biochemical Liver Function Via Lactate
Time frame: Days 1-7
Number of Participants With Evidence of Ischemia-Reperfusion Injury Via Comparison of Pre-Reperfusion Biopsies to Post-Reperfusion Biopsies
Overall Degree of Ischemia Reperfusion Injury (IRI) was categorized as: * None/Minimal: None or Polymorphonuclear Leukocytes (PMNs) in sinusoidal zone 3 with rare hepatocellular necrosis * Mild: Polymorphonuclear Leukocytes (PMNs) in sinusoidal zone 3 with ≥ 1 cluster of necrotic hepatocytes * Moderate/Severe: Clusters of hepatocellular necrosis in \> 50% of lobules or 60% of parenchyma or panlobular necrosis in \> 1 lobule
Time frame: 1 Day
Number of Participants With Biliary Investigations and Biliary Interventions
Time frame: 6 Months
Number of Livers Randomized But Not Transplanted
Time frame: 1 Day
Number of Livers That Did Not Experience a Safety Event
Number of livers that did not experience at least one of the following safety events: * Early Allograft Dysfunction (EAD) * Discard of a Retrieved Liver * Primary Non-Function (PNF)
Time frame: 10 Days
Assessment of the Health Economic Implications Via Length of ICU Stay and Length of Hospital Stay
Time frame: 6 Months
Compare Quality of Life Via the EQ-5D-5L Quality of Life Questionnaire
The EQ-5D-5L Questionnaire is the standard layout for recording an adult person's current self-reported health state. It consists of a standard format for respondents to record their health state according to the EQ-5D-5L descriptive system and the EQ Visual Analog Scale (VAS). EQ-5D-5L index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health. EQ-5D-5L is the name of the instrument and is not an acronym.
Time frame: 6 Months