A Study to Compare the Effects of Liver Preservation for Transplant via Normothermic Machine Perfusion, versus Static Cold Storage

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 16-007330
    NCT ID: NCT02775162
    Sponsor Protocol Number: WP01

About this study

The purpose of this study is to compare the effects of normothermic machine profusion versus static cold storage for preventing preservation-related graft injury in human livers for transplantation.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • 18 years of age or greater
  • Registered as an active recipient on the UNOS waiting list for liver transplantation
  • Subject, or legally authorized representative, is able and willing to give informed consent and HIPAA authorization
  • Able and willing to comply with all study requirements

Exclusion Criteria

  • Requires all of the following at the time of transplantation
    • Oxygen therapy
    • Inotropic support
    • Has acute/fulminant liver failure
  • Is undergoing simultaneous transplantation of more than one organ
  • Is pregnant or nursing
  • Concurrent enrollment in another clinical trial.
    • Enrollment in clinical trials or registries where only measurements and/or samples are taken (NO TEST DEVICE or TEST DRUG USED) is allowed

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Andrew Singer, M.D., Ph.D.

Contact us for the latest status

Contact information:

Vy Nguyen CCRP

(480)342-1328

Nguyen.Vy@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20304537

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