Global Utilization And Registry Database for Improved preservAtion of doNor Livers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LIVERguard.
- Who it may be relevant to
- Registry conditions: Liver Diseases, Liver Dysfunction, Liver Transplant Disorder, Liver Transplant Rejection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Global Utilization and Registry Database for Improved Preservation of Donor Livers
Overview
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
Detailed description
GUARDIAN-Liver is a post-market, observational registry of adult and pediatric liver transplant recipient patients whose donor liver was preserved and transported within the LIVERguard. The data is being collected retrospectively from medical records of patients already transplanted before the initiation of the registry and any new patients who meet the eligibility criteria.
About 1000 male and female subjects meeting the study inclusion and exclusion criteria will be enrolled into the study at about 20 clinical sites.
Candidates that fit the eligibility criteria and have had their donor liver transported with a Paragonix product or a standard of care method can be enrolled. The baseline characteristics and outcomes of the two groups will be compared.
Interventions
- Device LIVERguard
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.
Primary outcome measures
- Graft Failure [Time frame: Post-transplant through 1 year post]
- Early allograft dysfunction [Time frame: 7 days post transplant]
- Rejection [Time frame: Post-transplant through 1 year post]
- Primary Non-function [Time frame: Post transplant to 7 days post-transplant]
- Survival [Time frame: Transplant through 1 year post-transplant]
- Length of Stay [Time frame: 1 year]
- Length of ICU stay [Time frame: 1 year]
Secondary outcome measures (2)
- Hospitalizations [Time frame: post-transplant through 1 year]
- Biliary complications [Time frame: post-transplant through 1 year post-transplant]
Eligibility criteria
Inclusion criteria
- Donor and donor liver matched to the recipient based upon institutional medical practice
- Registered male or female primary liver transplant candidates
Exclusion criteria
- Donor and donor liver that do not meet institutional clinical requirements for transplantation
- Living donors
- Pediatric recipients (under 18)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 7 centers
- University of Alabama at Birmingham — Birmingham
- Stanford University — Stanford
- University of Florida — Gainesville
- Tampa General Hospital — Tampa
- University of Nebraska — Omaha
- Duke University — Durham
- University of Washington — Seattle
Identifiers
NCT: NCT05082077 · PGX-005