GUARDIAN-LIVER Registry
GUARDIAN-LUNG Registry
Study Product
The Paragonix LIVERguard™ is an FDA-cleared and 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 15 hours.
Study Objective
The objective of this registry is to collect and evaluate various clinical effectiveness parameters in patients transplanted with a donor liver that was preserved and transported within the LIVERguard system, as compared to the current ice and cooler standard of care.
Study Design
GUARDIAN-Liver is a post-market, observational registry of adult 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.
Study Center
Treatment Plan
No changes will be made to patient standard of care. Primary liver transplant candidates and retrospective patients will be screened for study eligibility. Every eligible candidate will be considered for enrollment. Eligible liver transplant candidates will be enrolled consecutively as they complete transplant 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.
Inclusion Criteria
DONOR: Donor and donor liver matched to the prospective recipient based upon institutional criteria
RECIPIENT: Registered male or female primary liver transplant candidates
Exclusion Criteria
DONOR:
- Donor and donor livers that do not meet institutional clinical requirements for recovery and/or transplantation
- Living donors
RECIPIENT: Pediatric patients (under 18)
Follow-Up Period
All subjects will be followed through 1-year following recipient transplant
Study Duration
On-going data collection through five years.
Outcome Measures
PRIMARY OUTCOME MEASURES:
- Collection and analysis of clinical and laboratory data from donor and transplant recipient subjects from which a donor liver was transported using the LIVERguard and other methods.
- Endpoints include: early allograft dysfunction, biliary strictures, and 30 day/1 year patient and graft survival.
Safety Measures
