WP01 - Normothermic Liver Preservation

Not Applicable

Completed

Conditions: Liver Transplantation

Registration Number: NCT02775162

Lead Sponsor: OrganOx Ltd.

Brief Summary: A multicenter randomized controlled trial to compare the efficacy of ex-vivo normothermic machine profusion with static cold storage in human liver transplantation.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 267

Inclusion Criteria

Subject is 18 years of age or greater
Subject is registered as an active recipient on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation
Subject, or legally authorized representative, is able and willing to give informed consent and HIPAA authorization
Subject is able and willing to comply with all study requirements

Exclusion Criteria

Subject requiring all of the following at the time of transplantation: oxygen therapy, inotropic support, renal replacement therapy
Subject has acute/fulminant liver failure
Subject undergoing simultaneous transplantation of more than one organ
Subject is pregnant or nursing
Concurrent enrollment in another clinical trial. Subjects enrolled in clinical trials or registries where only measurements and/or samples are taken (NO TEST DEVICE or TEST DRUG USED) are allowed to participate.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Early Allograft Dysfunction (EAD)	7 Days	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

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Primary Non-Function	10 Days	Primary Non-Function is defined in this study as irreversible graft dysfunction requiring emergency liver replacement during the first 10 days after liver transplantation.
Number of Participants With Graft Survival	6 Months
Number of Participants With Subject Survival	6 Months
Number of Participants With Post-Reperfusion Syndrome	1 Day	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.
Measure Biochemical Liver Function Via Bilirubin	6 Months
Measure Biochemical Liver Function Via Alkaline Phosphatase (ALP)	6 Months
Measure Biochemical Liver Function Via International Normalized Ratio (INR)	6 Months	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
Measure Biochemical Liver Function Via Lactate	Days 1-7
Number of Participants With Evidence of Ischemia-Reperfusion Injury Via Comparison of Pre-Reperfusion Biopsies to Post-Reperfusion Biopsies	1 Day	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
Measure Biochemical Liver Function Via Gamma-Glutamyl Transferase (GGT)	6 Months
Number of Participants With Biliary Investigations and Biliary Interventions	6 Months
Number of Livers Randomized But Not Transplanted	1 Day
Number of Livers That Did Not Experience a Safety Event	10 Days	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)
Assessment of the Health Economic Implications Via Length of ICU Stay and Length of Hospital Stay	6 Months
Compare Quality of Life Via the EQ-5D-5L Quality of Life Questionnaire	6 Months	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.
Measure Biochemical Liver Function Via Alanine Aminotransferase (ALT)	6 Months
Measure Biochemical Liver Function Via Aspartate Transaminase (AST)	6 Months

Trial Locations

Locations (15): University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Mayo Clinic - Phoenix
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Phoenix, Arizona, United States
University of Southern California (USC)
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Los Angeles, California, United States
University of California - Los Angeles (UCLA)
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Los Angeles, California, United States
University of California-San Francisco (UCSF)
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San Francisco, California, United States
University of Miami
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Miami, Florida, United States
Indiana University
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Indianapolis, Indiana, United States
Ochsner
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New Orleans, Louisiana, United States
University of Maryland
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Baltimore, Maryland, United States
University of Michigan
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Ann Arbor, Michigan, United States
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University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States