Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LungGuard, BAROGuard.
- Who it may be relevant to
- Registry conditions: Interstitial Lung Disease, COPD, Cystic Fibrosis, Pulmonary Fibrosis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Global Utilization and Registry Database for Improved Preservation of Donor Lungs
Overview
The objective of this registry is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor lung that were preserved and transported within the LUNGguard system, as well as retrospective standard of care patients
Detailed description
GUARDIAN-Lung is a post-market, observational registry of adult and pediatric lung transplant recipient patients whose donor lungs was preserved and transported within the LUNGguard. 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 500 male and female subjects (including pediatric patients) meeting the study inclusion and exclusion criteria will be enrolled into the study at about 5 clinical sites.
Candidates that fit the eligibility criteria and have had their donor lungs 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
- Device LungGuard
The LUNGguard is an FDA cleared and is a CE-marked medical device intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs. The intended organ storage time for the LUNGguard is up to 8 hours. - Device BAROGuard
The BAROguard (the "System") is ultraportable hypothermic preservation and transport system intended for use with donor lungs. BAROguard is a legally marketed, FDA cleared medical device in the United States. The intended organ storage time for BAROguard™ is up to 8 hours.
Primary outcome measures
- Number of subjects with Primary Graft Dysfunction (PGD) [Time frame: Post-transplant through 1 year post]
- Number of subjects with rejection [Time frame: Post-transplant through 1 year post]
- Survival [Time frame: Post-transplant through 1 year post]
- ICU Length of Stay [Time frame: Transplant through 1 year post-transplant]
- Hospital Length of Stay [Time frame: Transplant through 1 year post-transplant]
Secondary outcome measures (2)
- Number of rehospitalizations [Time frame: post-transplant through 1 year]
- How long subjects needed mechanical support [Time frame: pre-transplant through 48 hours post-transplant]
Eligibility criteria
Inclusion criteria
- Donor and donor lungs matched to the prospective recipient based upon institutional medical practice
- Registered male or female primary lung transplant candidates including pediatric candidates
Exclusion criteria
- Donor and donor lungs that do not meet institutional clinical requirements for transplantation
- Patients who are incarcerated persons (prisoners)
- Patients who have had a previous major organ transplant (heart, lungs, liver, kidney, pancreas)
- Patients who are receiving multiple organ transplants
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 14 centers
- St. Joseph's Hospital and Medical Center — Phoenix
- University of California, San Francisco — San Francisco
- Stanford Medicine — Stanford
- Mayo Clinic Jacksonville — Jacksonville
- Johns Hopkins University — Baltimore
- Massachusetts General Hospital — Boston
- Montefiore Hospital — The Bronx
- Duke Lung Transplant Clinic — Durham
- … and 6 more centers
Belgium · 1 center
- University Hospitals Leuven — Leuven
Identifiers
NCT: NCT04930289 · PGX-004