Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs

Study Overview
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Brief Summary
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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
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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.

Official Title
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Global Utilization and Registry Database for Improved Preservation of Donor Lungs

Conditions
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Interstitial Lung Disease, COPD, Cystic Fibrosis, Pulmonary Fibrosis, Pulmonary Arterial Hypertension, Emphysema

Intervention / Treatment
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* Device: LungGuard


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LungGuard patients<br>Patients whose donor lung(s) was transported with the LungGuard device. | Device: LungGuard<br>* 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.<br>|
| Standard Transport Patients<br>Patients whose donor lung(s) was transported with a method other than the LungGuard | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with Primary Graft Dysfunction (PGD) | The number of subjects that develop PGD after transplant | Post-transplant through 1 year post | 
| Number of subjects with rejection | Subjects that show signs to rejection after transplant | Post-transplant through 1 year post | 
| Survival | patient survival post-transplant | Post-transplant through 1 year post | 
| ICU Length of Stay | Days the subject spent the ICU post-transplant | Transplant through 1 year post-transplant | 
| Hospital Length of Stay | Days the subject was in the hospital in total after transplant | Transplant through 1 year post-transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of rehospitalizations | The number of times the subject was readmitted to the hospital after discharged post-transplant | post-transplant through 1 year | 
| How long subjects needed mechanical support | Amount of time (minutes) mechanical support (EMCO and ventilator) was needed pre and post transplant | pre-transplant through 48 hours post-transplant |