Paragonix is committed to improving the science and understanding of liver preservation and is leading GUARDIAN-Liver to enhance understanding of the impact of advanced organ preservation.The GUARDIAN-Liver Registry was established in October of 2021.
GUARDIAN-Liver will include transplant centers across the U.S. and Europe. The primary objectives of the post-market registry study are to evaluate short term post-transplant outcomes (initial hospital admission), intermediate term outcomes (3 and 6 month follow up) and long-term outcomes (1-year follow up) in patients with transplanted donor livers that were preserved and transported within the Paragonix LIVERguard™ Donor Liver Preservation System.
There will be no changes to existing standard protocols involved in donor liver transplantation. The registry study will also further analyze the impact of a variety of donor, recipient and transport-related parameters on patient outcomes, including donor clinical backgrounds, recipient factors and total ischemic times.
The Paragonix LIVERguard™ Donor Liver Preservation System has received FDA clearance 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 Paragonix LIVERguard™ Donor Preservation System is up to 15 hours.
GUARDIAN is a post-market clinical evaluation study. The study became WIRB approved in November 2021. The Paragonix LIVERguard™ Donor Preservation System utilized in this registry is cleared for marketing by the FDA and is CE Marked for its intended use.
The objective of GUARDIAN-Liver is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor livers that were preserved and transported within the Paragonix LIVERguard™ Donor Preservation System.
The GUARDIAN-Liver study is a post-market, observational registry of adult liver transplant recipient patients whose donor liver was preserved and transported using the Paragonix LIVERguard™ Donor Preservation System or standard of care methods. 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.
Up to 20 clinical sites will be included within the registry.
Primary liver transplant candidates and retrospective patients will be screened for study eligibility. Every eligible candidate can be enrolled in the study. Donor livers will be evaluated for suitability for transplantation and study eligibility. Eligible liver transplant candidates will be enrolled consecutively as they complete transplantation at each site. The decision of which transportation method to use for the donor liver will be made by each site’s physician irrespective of the study. No changes will be made to patient standard of care.
DONOR: Donor and donor livers matched to the prospective recipient based upon institutional medical practice.
RECIPIENT: Registered male or female primary liver transplant candidates.
DONOR: Donor and donor livers that do not meet institutional clinical requirements for transplantation. Living donors.
RECIPIENT: Pediatric patients <18 years of age.
All subjects will be followed through 1-year following liver transplantation (e.g., initial hospital admission, 3-month, 6-month, and 1-year).
On-going data collection through five years.
Collection and analysis of clinical and laboratory data from donor and transplant recipient subjects of which donor livers were transported using the Paragonix LIVERguard™ Donor Preservation System. Endpoints include post-reperfusion syndrome, early allograft dysfunction, biliary strictures, graft and patient survival (30 days/1year).
All relevant adverse events will be reported.