Clinical trial NCT05082077: Global Utilization And Registry Database for Improved preservAtion of doNor Livers
Official title: Global Utilization and Registry Database for Improved Preservation of Donor Livers
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Liver Diseases
Liver Dysfunction
Liver Transplant Disorder
Liver Transplant Rejection
Lead sponsor: Paragonix Technologies
Sponsor class: INDUSTRY
First posted: 2021-10-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have received a liver transplant at centers that use the LIVERguard device

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Graft Failure
timeFrame: Post-transplant through 1 year post
measure: Early allograft dysfunction
timeFrame: 7 days post transplant
measure: Rejection
timeFrame: Post-transplant through 1 year post
measure: Primary Non-function
timeFrame: Post transplant to 7 days post-transplant
measure: Survival
timeFrame: Transplant through 1 year post-transplant
measure: Length of Stay
timeFrame: 1 year
measure: Length of ICU stay
timeFrame: 1 year
Secondary outcomes:
measure: Hospitalizations
timeFrame: post-transplant through 1 year
measure: Biliary complications
timeFrame: post-transplant through 1 year post-transplant
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Stanford
country: United States
facility: Stanford University
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Methodist Le Bonheur Healthcare
name: Jason Vanatta, MD
role: PRINCIPAL_INVESTIGATOR
References: