Global Utilization And Registry Database for Improved preservAtion of doNor Livers
Global Utilization and Registry Database for Improved Preservation of Donor Livers
1 other identifier
observational
1,000
1 country
7
Brief Summary
The objective of this registry is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor liver that were preserved and transported within the LIVERguard system, as well as retrospective standard of care patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2021
CompletedFirst Posted
Study publicly available on registry
October 18, 2021
CompletedStudy Start
First participant enrolled
March 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
May 15, 2025
July 1, 2024
5.4 years
September 24, 2021
May 12, 2025
Conditions
Outcome Measures
Primary Outcomes (7)
Graft Failure
The percentage of subjects in each cohort who develop graft failure post-transplant
Post-transplant through 1 year post
Early allograft dysfunction
The percentage of subjects in each cohort who early allograft failure post-transplant
7 days post transplant
Rejection
The percentage of subjects in each cohort who experience rejection post-transplant
Post-transplant through 1 year post
Primary Non-function
The percentage of subjects in each cohort who experience primary non-function post-transplant
Post transplant to 7 days post-transplant
Survival
The percentage of subjects in each cohort who survive through 1 year post-transplant
Transplant through 1 year post-transplant
Length of Stay
How many days the patient stays in the hospital post-transplant
1 year
Length of ICU stay
How many days the patient stayed in the ICU post-transplant
1 year
Secondary Outcomes (2)
Hospitalizations
post-transplant through 1 year
Biliary complications
post-transplant through 1 year post-transplant
Study Arms (2)
LIVERguard patient
Patients whose donor liver was transported with the LiverGuard device.
Standard Transport Patients
Patients whose donor liver was transported with a method other than the LiverGuard
Interventions
The LIVERguard is an FDA cleared and is a CE-marked medical device intended to be used for the static hypothermic preservation of livers during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the liver. The intended organ storage time for the LIVERguard is up to 16 hours.
Eligibility Criteria
Patients who have received a liver transplant at centers that use the LIVERguard device
You may qualify if:
- Donor and donor liver matched to the recipient based upon institutional medical practice
- Registered male or female primary liver transplant candidates
You may not qualify if:
- Donor and donor liver that do not meet institutional clinical requirements for transplantation
- Living donors
- Pediatric recipients (under 18)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Stanford University
Stanford, California, 94305, United States
University of Florida
Gainesville, Florida, 32608, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
University of Nebraska
Omaha, Nebraska, 68198, United States
Duke University
Durham, North Carolina, 27710, United States
University of Washington
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Vanatta, MD
Methodist Le Bonheur Healthcare
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Year
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2021
First Posted
October 18, 2021
Study Start
March 15, 2022
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
May 15, 2025
Record last verified: 2024-07