NCT Number: NCT05082077
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
Interested in participating?
Request Info18 year and older
All sexes
Observational
University of Alabama at Birmingham, Birmingham, Alabama, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Post-transplant through 1 year post
The percentage of subjects in each cohort who develop graft failure post-transplant
Time frame: 7 days post transplant
The percentage of subjects in each cohort who early allograft failure post-transplant
Time frame: Post-transplant through 1 year post
The percentage of subjects in each cohort who experience rejection post-transplant
Time frame: Post transplant to 7 days post-transplant
The percentage of subjects in each cohort who experience primary non-function post-transplant
Time frame: Transplant through 1 year post-transplant
The percentage of subjects in each cohort who survive through 1 year post-transplant
Time frame: 1 year
How many days the patient stays in the hospital post-transplant
Time frame: 1 year
How many days the patient stayed in the ICU post-transplant
Time frame: post-transplant through 1 year
Amount of times patient is rehospitalized after discharge post-transplant
Time frame: post-transplant through 1 year post-transplant
Percentage of patients that experience biliary strictures in each cohort as determined by lab work
Paragonix Technologies
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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