Liver Diseases Clinical Trial
Official title:
Global Utilization and Registry Database for Improved Preservation of Donor Livers
Verified date | March 2024 |
Source | Paragonix Technologies |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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
Status | Enrolling by invitation |
Enrollment | 1000 |
Est. completion date | January 2026 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Duke University | Durham | North Carolina |
United States | University of Florida | Gainesville | Florida |
United States | University of Nebraska | Omaha | Nebraska |
United States | University of Washington | Seattle | Washington |
United States | Stanford University | Stanford | California |
United States | Tampa General Hospital | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Paragonix Technologies |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Graft Failure | The percentage of subjects in each cohort who develop graft failure post-transplant | Post-transplant through 1 year post | |
Primary | Early allograft dysfunction | The percentage of subjects in each cohort who early allograft failure post-transplant | 7 days post transplant | |
Primary | Rejection | The percentage of subjects in each cohort who experience rejection post-transplant | Post-transplant through 1 year post | |
Primary | Primary Non-function | The percentage of subjects in each cohort who experience primary non-function post-transplant | Post transplant to 7 days post-transplant | |
Primary | Survival | The percentage of subjects in each cohort who survive through 1 year post-transplant | Transplant through 1 year post-transplant | |
Primary | Length of Stay | How many days the patient stays in the hospital post-transplant | 1 year | |
Primary | Length of ICU stay | How many days the patient stayed in the ICU post-transplant | 1 year | |
Secondary | Hospitalizations | Amount of times patient is rehospitalized after discharge post-transplant | post-transplant through 1 year | |
Secondary | Biliary complications | Percentage of patients that experience biliary strictures in each cohort as determined by lab work | post-transplant through 1 year post-transplant |
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