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Clinical Trials in the USA / NCT05082077
Enrolling by invitation Observational

Global Utilization And Registry Database for Improved preservAtion of doNor Livers

NCT05082077 · tracked via the Priya Life Science USA tracker
Sponsor
Paragonix Technologies
Phase
Observational
Started
2022-03-15
Last updated
2026-09-17

Condition(s) studied

Liver DiseasesLiver DysfunctionLiver Transplant DisorderLiver Transplant Rejection

Investigational drug(s) / intervention(s)

LIVERguard

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.

Study 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

Eligibility

Sex
ALL
Min age
—
Max age
—
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

Primary outcome measure(s)

  • 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

Trial sites (15)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
University of California San Diego San Diego California
Stanford University Stanford California
University of Florida Gainesville Florida
Mayo Clinic Jacksonville Jacksonville Florida
Tampa General Hospital Tampa Florida
Piedmont Healthcare Atlanta Georgia
University of Maryland, Baltimore Baltimore Maryland
Lahey Clinic Burlington Massachusetts
University of Nebraska Omaha Nebraska
Duke University Durham North Carolina
University of Cincinnati Cincinnati Ohio
University of Texas Health Science Center at San Antonio San Antonio Texas
Intermountain Health Center Salt Lake City Utah
University of Washington Seattle Washington

More Paragonix Technologies trials in the USA

Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs Enrolling by invitation
Global Utilization And Registry Database for Improved heArt preservatioN Enrolling by invitation

Other trials for the same condition

Observational Pharmaco-Epidemiology Research & Analysis Recruiting
A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Moderate or Severe Hepatic Impairment Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05082077 on ClinicalTrials.gov ↗ ← All trials in the USA