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.

The Paragonix LUNGguard DLPS

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:

  1. Number of subjects with Primary Graft Dysfunction (PGD)
  2. Number of subjects with rejection
  3. Survival
  4. ICU Length of Stay
  5. Hospital Length of Stay

 

SECONDARY OUTCOME MEASURES:

  1. Number of re-hospitalizations
  2. How long subjects needed mechanical support

Safety Measures​​

All relevant adverse events will be reported.
GUARDIANLUNG

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