Global Utilization And Registry Database for Improved preservAtion of doNor Livers

Global Utilization and Registry Database for Improved Preservation of Donor Livers

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Liver Diseases; Liver Transplant Disorder; Liver Dysfunction; Liver Transplant Rejection
• Intervention / Treatment: Device: LIVERguard

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • California
    • Stanford, California, United States, 94305
      • Stanford University
  • Florida
    • Gainesville, Florida, United States, 32608
      • University of Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Washington
    • Seattle, Washington, United States, 98109
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have received a liver transplant at centers that use the LIVERguard device

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Donor and donor liver that do not meet institutional clinical requirements for transplantation
• Living donors
• Pediatric recipients (under 18)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LIVERguard patient; Patients whose donor liver was transported with the LiverGuard device.	Device: LIVERguard; 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.
Standard Transport Patients; Patients whose donor liver was transported with a method other than the LiverGuard

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft Failure	The percentage of subjects in each cohort who develop graft failure post-transplant	Post-transplant through 1 year post
Early allograft dysfunction	The percentage of subjects in each cohort who early allograft failure post-transplant	7 days post transplant
Rejection	The percentage of subjects in each cohort who experience rejection post-transplant	Post-transplant through 1 year post
Primary Non-function	The percentage of subjects in each cohort who experience primary non-function post-transplant	Post transplant to 7 days post-transplant
Survival	The percentage of subjects in each cohort who survive through 1 year post-transplant	Transplant through 1 year post-transplant
Length of Stay	How many days the patient stays in the hospital post-transplant	1 year
Length of ICU stay	How many days the patient stayed in the ICU post-transplant	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalizations	Amount of times patient is rehospitalized after discharge post-transplant	post-transplant through 1 year
Biliary complications	Percentage of patients that experience biliary strictures in each cohort as determined by lab work	post-transplant through 1 year post-transplant

Collaborators and Investigators

• Sponsor: Paragonix Technologies
• Investigators: Principal Investigator: Jason Vanatta, MD, Methodist Le Bonheur Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: September 24, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: PGX-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No