WP01 - Normothermic Liver Preservation
A Multicenter Randomized Controlled Trial to Compare the Efficacy of Ex-vivo Normothermic Machine Perfusion With Static Cold Storage in Human Liver Transplantation
1 other identifier
interventional
267
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2016
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2016
CompletedFirst Posted
Study publicly available on registry
May 17, 2016
CompletedStudy Start
First participant enrolled
October 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 19, 2021
CompletedResults Posted
Study results publicly available
July 22, 2022
CompletedJuly 29, 2022
July 1, 2022
3.3 years
March 30, 2016
May 16, 2022
July 26, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Early Allograft Dysfunction (EAD)
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
7 Days
Secondary Outcomes (17)
Number of Participants With Primary Non-Function
10 Days
Number of Participants With Graft Survival
6 Months
Number of Participants With Subject Survival
6 Months
Number of Participants With Post-Reperfusion Syndrome
1 Day
Measure Biochemical Liver Function Via Bilirubin
6 Months
- +12 more secondary outcomes
Study Arms (2)
Normothermic Machine Perfusion (NMP)
EXPERIMENTALFollowing 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.
Standard of Care (Ice)
OTHERFollowing 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OrganOx Ltd.lead
- North American Science Associates Ltd.collaborator
Study Sites (15)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Mayo Clinic - Phoenix
Phoenix, Arizona, 85054, United States
University of Southern California (USC)
Los Angeles, California, 90033, United States
University of California - Los Angeles (UCLA)
Los Angeles, California, 90095, United States
University of California-San Francisco (UCSF)
San Francisco, California, 94153, United States
University of Miami
Miami, Florida, 33136, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Ochsner
New Orleans, Louisiana, 70121, United States
University of Maryland
Baltimore, Maryland, 21201, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Washington University
St Louis, Missouri, 63110, United States
Duke University
Durham, North Carolina, 27710, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
University of Wisconsin Madison
Madison, Wisconsin, 53792, United States
Related Publications (1)
Kubal C, Mihaylov P, Holden J. Oncologic indications of liver transplantation and deceased donor liver allocation in the United States. Curr Opin Organ Transplant. 2021 Apr 1;26(2):168-175. doi: 10.1097/MOT.0000000000000866.
PMID: 33650998DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert Bovy, VP of Regulatory Affairs, North America
- Organization
- OrganOx Ltd
Study Officials
- PRINCIPAL INVESTIGATOR
Stuart Knechtle, MD
Duke University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2016
First Posted
May 17, 2016
Study Start
October 9, 2016
Primary Completion
February 10, 2020
Study Completion
February 19, 2021
Last Updated
July 29, 2022
Results First Posted
July 22, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share