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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02775162
Recruitment Status : Active, not recruiting
First Posted : May 17, 2016
Last Update Posted : February 18, 2020
Sponsor:
Collaborator:
North American Science Associates (NAMSA)
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
Estimated Study Completion Date : March 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. Measure early allograft dysfunction (EAD) [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Measure primary non-function rates [ Time Frame: 10 days ]
  2. Measure graft survival rates [ Time Frame: 6 months ]
  3. Measure subject survival rates [ Time Frame: 6 months ]
  4. Measure post-reperfusion syndrome via mean arterial pressure (MAP) [ Time Frame: 1 day ]
  5. Measure biochemical liver function via Bilirubin, GGT, ALT, AST, ALP, INR, and Lactate [ Time Frame: 6 months ]
  6. Measure evidence of ischemia-reperfusion injury via comparison of pre-reperfusion biopsies to post-reperfusion biopsies [ Time Frame: 1 day ]
  7. Measure evidence of biliary complications [ Time Frame: 6 months ]
  8. Measure incidence of livers randomized but not transplanted [ Time Frame: 1 day ]
  9. Measure organ utilization [ Time Frame: 10 days ]
  10. Measure healthcare costs [ Time Frame: 6 months ]
  11. Measure quality of life measures [ Time Frame: 6 months ]


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

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.

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


Locations
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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
Ochsner
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 (NAMSA)
Investigators
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Principal Investigator: Stuart Knechtle, MD Duke University
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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
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No