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Completed

NCT Number: NCT02775162

WP01 - Normothermic Liver Preservation

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

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Key information

Conditions

Liver Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Normothermic Machine Perfusion (NMP)

Device

Other names: OrganOx metra® device

Standard of Care (Ice)

Other

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

OrganOx Ltd.

Industry

Collaborators

  • North American Science Associates Ltd.

Registry information

Official study title

A Multicenter Randomized Controlled Trial to Compare the Efficacy of Ex-vivo Normothermic Machine Perfusion With Static Cold Storage in Human Liver Transplantation

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
May 17, 2016
Registry last updated
Jul 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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