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
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.
Study Type
OBSERVATIONAL
Enrollment
1,000
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.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Stanford University
Stanford, California, United States
University of Florida
Gainesville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Graft Failure
The percentage of subjects in each cohort who develop graft failure post-transplant
Time frame: Post-transplant through 1 year post
Early allograft dysfunction
The percentage of subjects in each cohort who early allograft failure post-transplant
Time frame: 7 days post transplant
Rejection
The percentage of subjects in each cohort who experience rejection post-transplant
Time frame: Post-transplant through 1 year post
Primary Non-function
The percentage of subjects in each cohort who experience primary non-function post-transplant
Time frame: Post transplant to 7 days post-transplant
Survival
The percentage of subjects in each cohort who survive through 1 year post-transplant
Time frame: Transplant through 1 year post-transplant
Length of Stay
How many days the patient stays in the hospital post-transplant
Time frame: 1 year
Length of ICU stay
How many days the patient stayed in the ICU post-transplant
Time frame: 1 year
Hospitalizations
Amount of times patient is rehospitalized after discharge post-transplant
Time frame: post-transplant through 1 year
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University of Nebraska
Omaha, Nebraska, United States
Duke University
Durham, North Carolina, United States
University of Washington
Seattle, Washington, United States
Biliary complications
Percentage of patients that experience biliary strictures in each cohort as determined by lab work
Time frame: post-transplant through 1 year post-transplant