GUARDIAN-LUNG Registry
GUARDIAN-LUNG Registry
Study Synopsis
GUARDIAN-LUNG will include transplant centers across the U.S. and Europe. The primary objectives of the post-market registry study are to evaluate short term post-transplant outcomes (within the first 48 hours), intermediate term outcomes (3- and 6-month follow-up) and long-term outcomes (1-year follow-up).
There will be no changes to existing standard protocols involved in donor lung transplantation. The registry study will also further analyze the impact of a variety of donor, recipient and transport-related parameters on patient outcomes, including donor clinical backgrounds, total ischemic times and recipient factors.
Study Product
The Paragonix LUNGguard™ Donor Lung Preservation System (DLPS) has received FDA clearance 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 lung. The intended organ storage time for the Paragonix LUNGguard DLPS is up to 8 hours.
Study Objective
The objective of GUARDIAN-LUNG is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor lungs that were preserved and transported within the Paragonix LUNGguard DLPS.
Study Design
The GUARDIAN-LUNG study is a post-market, observational registry of adult and pediatric lung transplant recipient patients whose donor lung was preserved and transported using the Paragonix LUNGguard DLPS or standard of care methods. 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.
Study Center
Up to 10 clinical sites will be included within this registry.
Treatment Plan
Primary lung transplant candidates and retrospective patients will be screened for study eligibility. Every eligible candidate can be enrolled in the study. Donor lungs will be evaluated for suitability for transplantation and study eligibility. Eligible lung transplant candidates will be enrolled consecutively as they complete transplant at each site. The decision of which transportation method to use for the donor lung will be made by each site’s physician irrespective of the study.
Inclusion Criteria
DONOR: Donor and donor lungs matched to the prospective recipient based upon institutional medical practice
RECIPIENT: Registered male or female primary lung transplant candidates including pediatric candidates
Exclusion Criteria
RECIPIENT: Donor and donor lungs that do not meet institutional clinical requirements for transplantation. As well as patients who are incarcerated persons (prisoners), patients who have had a previous major organ transplant (heart, lungs, liver, kidney, pancreas), and patients who are receiving multiple organ transplants.
DONOR: Patients who are incarcerated persons (prisoners), patients who have had a previous major organ transplant (heart, lungs, liver, kidney, pancreas), and patients who are receiving multiple organ transplants.
Follow-Up Period
All subjects will be followed through 1-year following recipient transplant (e.g., 24 hours, discharge, 3-month, 6-month, and 1-year).
Study Duration
On-going data collection through tree years.
Outcome Measures
PRIMARY OUTCOME MEASURES:
- Number of subjects with Primary Graft Dysfunction (PGD)
- Number of subjects with rejection
- Survival
- ICU Length of Stay
- Hospital Length of Stay
SECONDARY OUTCOME MEASURES:
- Number of re-hospitalizations
- How long subjects needed mechanical support
Safety Measures
