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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LungGuard patients | Patients whose donor lung(s) was transported with the LungGuard device. |
| |
| Standard Transport Patients | Patients whose donor lung(s) was transported with a method other than the LungGuard | ||
| BAROGuard Patients | Patients whose donor lung(s) was transported with the BAROGuard device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LungGuard | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Primary lung transplant candidates at centers that use the LungGuard device
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Hartwig, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | United States | ||
| University of California, San Francisco |
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|
| BAROGuard | Device | 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. |
|
Amount of time (minutes) mechanical support (EMCO and ventilator) was needed pre and post transplant
| pre-transplant through 48 hours post-transplant |
| San Francisco |
| California |
| 94143 |
| United States |
| Stanford Medicine | Stanford | California | 94305 | United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21218 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Montefiore Hospital | The Bronx | New York | 10467 | United States |
| Duke Lung Transplant Clinic | Durham | North Carolina | 27710 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Baylor Scott & White Research Institute | Dallas | Texas | 75246 | United States |
| The University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| University Hospitals Leuven | Leuven | 3000 | Belgium |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D003550 | Cystic Fibrosis |
| D011658 | Pulmonary Fibrosis |
| D000081029 | Pulmonary Arterial Hypertension |
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D005355 | Fibrosis |
| D006976 | Hypertension, Pulmonary |
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