Global Utilization And Registry Database for Improved preservAtion of doNor Livers

• Conditions: Liver Transplant Rejection; Liver Transplant Disorder; Liver Diseases; Liver Dysfunction
• Interventions: Device: LIVERguard

• Registration Number: NCT05082077
• Lead Sponsor: Paragonix Technologies

Brief 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

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 Timeline

• Study First Submitted: 2021-09-24
• Study First Submitted QC: 2021-10-05
• Study First Posted: 2021-10-18
• Study Start: 2022-03-15
• Status Verified: 2024-07
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2027-08
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LIVERguard patient	LIVERguard	Patients whose donor liver was transported with the LiverGuard device.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Stanford University; 🇺🇸 Stanford, California, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Nebraska; 🇺🇸 Omaha, Nebraska, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States