Summary

Location
at San Diego, California and other locations
Dates
study started
study ends around

Description

Summary

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

Official Title

Global Utilization and Registry Database for Improved Preservation of Donor Livers

Details

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 2,000 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.

Keywords

Liver Diseases, Liver Dysfunction, Liver Transplant Disorder, Liver Transplant Rejection, LIVERguard

Eligibility

You can join if…

  • Donor and donor liver matched to the recipient based upon institutional medical practice
  • Registered male or female liver transplant candidates

You CAN'T join if...

  • Donor and donor liver that do not meet institutional clinical requirements for transplantation
  • Living donors

Locations

  • University of California San Diego
    San Diego California 92093-0990 United States
  • Stanford University
    Stanford California 94305 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Paragonix Technologies
ID
NCT05082077
Study Type
Observational [Patient Registry]
Participants
Expecting 2000 study participants
Last Updated