Global Utilization And Registry Database for Improved preservAtion of doNor Livers

Liver Diseases Clinical Trial

Official title:

Global Utilization and Registry Database for Improved Preservation of Donor Livers

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05082077
• Other study ID #: PGX-005
• Status: Enrolling by invitation
• Start date: March 15, 2022
• Est. completion date: January 2026

Study information

• Verified date: March 2024
• Source: Paragonix Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: January 2026
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Liver Diseases
• Liver Dysfunction
• Liver Transplant Disorder
• Liver Transplant Rejection

Intervention

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Duke University	Durham	North Carolina
United States	University of Florida	Gainesville	Florida
United States	University of Nebraska	Omaha	Nebraska
United States	University of Washington	Seattle	Washington
United States	Stanford University	Stanford	California
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Paragonix Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft Failure	The percentage of subjects in each cohort who develop graft failure post-transplant	Post-transplant through 1 year post
Primary	Early allograft dysfunction	The percentage of subjects in each cohort who early allograft failure post-transplant	7 days post transplant
Primary	Rejection	The percentage of subjects in each cohort who experience rejection post-transplant	Post-transplant through 1 year post
Primary	Primary Non-function	The percentage of subjects in each cohort who experience primary non-function post-transplant	Post transplant to 7 days post-transplant
Primary	Survival	The percentage of subjects in each cohort who survive through 1 year post-transplant	Transplant through 1 year post-transplant
Primary	Length of Stay	How many days the patient stays in the hospital post-transplant	1 year
Primary	Length of ICU stay	How many days the patient stayed in the ICU post-transplant	1 year
Secondary	Hospitalizations	Amount of times patient is rehospitalized after discharge post-transplant	post-transplant through 1 year
Secondary	Biliary complications	Percentage of patients that experience biliary strictures in each cohort as determined by lab work	post-transplant through 1 year post-transplant