Global Utilization And Registry Database for Improved preservAtion of doNor Livers
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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 |
Outcome Measures
Primary Outcome Measures
- Graft Failure [Post-transplant through 1 year post]
The percentage of subjects in each cohort who develop graft failure post-transplant
- Early allograft dysfunction [7 days post transplant]
The percentage of subjects in each cohort who early allograft failure 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
- Survival [Transplant through 1 year post-transplant]
The percentage of subjects in each cohort who survive through 1 year post-transplant
- Length of Stay [1 year]
How many days the patient stays in the hospital post-transplant
- Length of ICU stay [1 year]
How many days the patient stayed in the ICU post-transplant
Secondary Outcome Measures
- 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
Eligibility Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke University | Durham | North Carolina | United States | 27710 |
Sponsors and Collaborators
- Paragonix Technologies
Investigators
- Principal Investigator: James Eason, MD, Methodist Le Bonheur Healthcare
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PGX-005