Transplant Surgery »  Research »  Clinical Research »  Clinical Trials »  OrganOx 15-18334

WP01 - Normothermic Liver Preservation

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

Basic Trial Information

Phase Type Age Sponsor Protocol IDs Status
Phase 3 Interventional 18 Years and older OrganOx Ltd. WP01
NCT02775162
Enrolling patients

Study Design:


Principal Investigator

Professor of Surgery
Division of Transplant Surgery
Director, Abdominal Transplant Fellowship Program

Clinical Research Coordinator

UCSF Medical Center at Parnassus
(415) 514-0192 Phone

Trial Summary

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

Eligibility

Inclusion Criteria:
  • Subject is 18 years of age or greater
  • Subject is 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
  • 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.

Important

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.

Information about this trial was obtained from the NIH Clinical Trials website, http://clinicaltrials.gov on 1/26/2017. UCSF specific information including the PI (Principal Investigator), trial enrollment status, and UCSF Study ID, supplement the ClinicalTrials.gov study posting.
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