Global Utilization And Registry Database for Improved preservAtion of doNor Livers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Global Utilization and Registry Database for Improved Preservation of Donor Livers

Conditions
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Liver Diseases, Liver Dysfunction, Liver Transplant Disorder, Liver Transplant Rejection

Intervention / Treatment
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* Device: LIVERguard


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LIVERguard patient<br>Patients whose donor liver was transported with the LiverGuard device. | Device: LIVERguard<br>* 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.<br>|
| Standard Transport Patients<br>Patients whose donor liver was transported with a method other than the LiverGuard | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft Failure | The percentage of subjects in each cohort who develop graft failure post-transplant | Post-transplant through 1 year post | 
| Early allograft dysfunction | The percentage of subjects in each cohort who early allograft failure post-transplant | 7 days post transplant | 
| Rejection | The percentage of subjects in each cohort who experience rejection post-transplant | Post-transplant through 1 year post | 
| Primary Non-function | The percentage of subjects in each cohort who experience primary non-function post-transplant | Post transplant to 7 days post-transplant | 
| Survival | The percentage of subjects in each cohort who survive through 1 year post-transplant | Transplant through 1 year post-transplant | 
| Length of Stay | How many days the patient stays in the hospital post-transplant | 1 year | 
| Length of ICU stay | How many days the patient stayed in the ICU post-transplant | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalizations | Amount of times patient is rehospitalized after discharge post-transplant | post-transplant through 1 year | 
| Biliary complications | Percentage of patients that experience biliary strictures in each cohort as determined by lab work | post-transplant through 1 year post-transplant |