GUARDIAN-LIVER Registry

GUARDIAN-LUNG Registry

GUARDIAN-Liver 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.

The Paragonix LIVERguard DLPS

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​​

Up to 20 clinical sites will be included within this registry.

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​​

All relevant adverse events will be reported.

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