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Trial record 1 of 1 for:    OrganOx NCT02775162
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WP01 - Normothermic Liver Preservation

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ClinicalTrials.gov Identifier: NCT02775162
Recruitment Status : Completed
First Posted : May 17, 2016
Results First Posted : July 22, 2022
Last Update Posted : July 29, 2022
North American Science Associates Ltd.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Liver Transplantation Device: Normothermic Machine Perfusion (NMP) Other: Standard of Care (Ice) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Controlled Trial to Compare the Efficacy of Ex-vivo Normothermic Machine Perfusion With Static Cold Storage in Human Liver Transplantation
Actual Study Start Date : October 9, 2016
Actual Primary Completion Date : February 10, 2020
Actual Study Completion Date : February 19, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Normothermic Machine Perfusion (NMP)
Following the routine retrieval procedure of the liver, it will be placed on the OrganOx metra for Normothermic Machine Perfusion (NMP) for transport per the Investigational Plan and the Instructions For Use.
Device: Normothermic Machine Perfusion (NMP)
Other Name: OrganOx metra® device

Standard of Care (Ice)
Following the routine retrieval procedure of the liver, it will be placed in ice-cold perfusion solution within an ice box for transport as dictated by logistics and local policy.
Other: Standard of Care (Ice)

Primary Outcome Measures :
  1. Percentage of Participants With Early Allograft Dysfunction (EAD) [ Time Frame: 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 :
  1. Number of Participants With Primary Non-Function [ Time Frame: 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.

  2. Number of Participants With Graft Survival [ Time Frame: 6 Months ]
  3. Number of Participants With Subject Survival [ Time Frame: 6 Months ]
  4. Number of Participants With Post-Reperfusion Syndrome [ Time Frame: 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.

  5. Measure Biochemical Liver Function Via Bilirubin [ Time Frame: 6 Months ]
  6. Measure Biochemical Liver Function Via Gamma-Glutamyl Transferase (GGT) [ Time Frame: 6 Months ]
  7. Measure Biochemical Liver Function Via Alanine Aminotransferase (ALT) [ Time Frame: 6 Months ]
  8. Measure Biochemical Liver Function Via Aspartate Transaminase (AST) [ Time Frame: 6 Months ]
  9. Measure Biochemical Liver Function Via Alkaline Phosphatase (ALP) [ Time Frame: 6 Months ]
  10. Measure Biochemical Liver Function Via International Normalized Ratio (INR) [ Time Frame: 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

  11. Measure Biochemical Liver Function Via Lactate [ Time Frame: Days 1-7 ]
  12. Number of Participants With Evidence of Ischemia-Reperfusion Injury Via Comparison of Pre-Reperfusion Biopsies to Post-Reperfusion Biopsies [ Time Frame: 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

  13. Number of Participants With Biliary Investigations and Biliary Interventions [ Time Frame: 6 Months ]
  14. Number of Livers Randomized But Not Transplanted [ Time Frame: 1 Day ]
  15. Number of Livers That Did Not Experience a Safety Event [ Time Frame: 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)

  16. Assessment of the Health Economic Implications Via Length of ICU Stay and Length of Hospital Stay [ Time Frame: 6 Months ]
  17. Compare Quality of Life Via the EQ-5D-5L Quality of Life Questionnaire [ Time Frame: 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02775162

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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Mayo Clinic - Phoenix
Phoenix, Arizona, United States, 85054
United States, California
University of Southern California (USC)
Los Angeles, California, United States, 90033
University of California - Los Angeles (UCLA)
Los Angeles, California, United States, 90095
University of California-San Francisco (UCSF)
San Francisco, California, United States, 94153
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Louisiana
New Orleans, Louisiana, United States, 70121
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Wisconsin
University of Wisconsin Madison
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
OrganOx Ltd.
North American Science Associates Ltd.
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Principal Investigator: Stuart Knechtle, MD Duke University
  Study Documents (Full-Text)

Documents provided by OrganOx Ltd.:
Study Protocol  [PDF] June 24, 2016
Statistical Analysis Plan  [PDF] September 9, 2020

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: OrganOx Ltd.
ClinicalTrials.gov Identifier: NCT02775162    
Other Study ID Numbers: WP01
First Posted: May 17, 2016    Key Record Dates
Results First Posted: July 22, 2022
Last Update Posted: July 29, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No