Liver Diseases, Liver Dysfunction, Liver Transplant Disorder, Liver Transplant Rejection
Conditions
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 2,000 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.
Interventions
DEVICELIVERguard
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.
Sponsors
Paragonix Technologies
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Donor and donor liver matched to the recipient based upon institutional medical practice * Registered male or female liver transplant candidates
Exclusion criteria
* Donor and donor liver that do not meet institutional clinical requirements for transplantation * Living donors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJason Vanatta, MD
Methodist Le Bonheur Healthcare
Outcome results
None listed