Global Utilization and Registry Database for Improved Preservation of Donor Livers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Liver Diseases
- Sponsor
- Paragonix Technologies
- Enrollment
- 1000
- Locations
- 7
- Primary Endpoint
- Early allograft dysfunction
- Status
- Enrolling By Invitation
- Last Updated
- 11 months ago
Overview
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.
Investigators
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)
Outcomes
Primary Outcomes
Early allograft dysfunction
Time Frame: 7 days post transplant
The percentage of subjects in each cohort who early allograft failure post-transplant
Survival
Time Frame: Transplant through 1 year post-transplant
The percentage of subjects in each cohort who survive through 1 year post-transplant
Length of ICU stay
Time Frame: 1 year
How many days the patient stayed in the ICU post-transplant
Length of Stay
Time Frame: 1 year
How many days the patient stays in the hospital post-transplant
Rejection
Time Frame: Post-transplant through 1 year post
The percentage of subjects in each cohort who experience rejection post-transplant
Primary Non-function
Time Frame: Post transplant to 7 days post-transplant
The percentage of subjects in each cohort who experience primary non-function post-transplant
Graft Failure
Time Frame: Post-transplant through 1 year post
The percentage of subjects in each cohort who develop graft failure post-transplant
Secondary Outcomes
- Hospitalizations(post-transplant through 1 year)
- Biliary complications(post-transplant through 1 year post-transplant)