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WP01 - Normothermic Liver Preservation

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ClinicalTrials.gov Identifier: NCT02775162
Recruitment Status : Recruiting
First Posted : May 17, 2016
Last Update Posted : July 17, 2018
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) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 266 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
Study Start Date : June 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

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


Contacts
Contact: Andy Self +44 (0) 1865 784154 andy.self@organox.com
Contact: Marie Barrigar 650-338-8854 mbarrigar@namsa.com

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Devin Eckhoff, MD    205-975-7622      
United States, Arizona
Mayo Clinic - Phoenix Recruiting
Phoenix, Arizona, United States, 85054
Contact: Andrew Singer, MD, PhD    480-342-3771      
United States, California
University of Southern California (USC) Recruiting
Los Angeles, California, United States, 90033
Contact: Yuri Genyk, MD    323-442-5908      
University of California - Los Angeles (UCLA) Recruiting
Los Angeles, California, United States, 90095
Contact: Hasan Yersiz, MD    310-267-9591      
University of California-San Francisco (UCSF) Active, not recruiting
San Francisco, California, United States, 94153
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Rodrigo Vianna, MD    305-355-5315      
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Chandrashekhar Kubal, MD    317-312-2601      
United States, Louisiana
Ochsner Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Ari Cohen, MD    504-842-3925      
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Rolf Barth, MD    410-328-6020      
Contact: Sheehan Wheeler    410-328-0303      
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Christopher Sonnenday, MD    734-936-5962      
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: William Chapman, MD    314-362-7792      
United States, North Carolina
Duke Recruiting
Durham, North Carolina, United States, 27710
Contact: Deb Sudan, MD    919-668-2279      
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Abt Peter, MD    215-662-2094      
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Sophoclis Alexopoulos, MD    615-936-0420      
United States, Wisconsin
University of Wisconsin Madison Recruiting
Madison, Wisconsin, United States, 53792
Contact: Anthony D'Alessandro, MD    608-263-9501      
Sponsors and Collaborators
OrganOx Ltd.
North American Science Associates (NAMSA)

Responsible Party: OrganOx Ltd.
ClinicalTrials.gov Identifier: NCT02775162     History of Changes
Other Study ID Numbers: WP01
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No