Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs (GUARDIANLUNG)
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|ClinicalTrials.gov Identifier: NCT04930289|
Recruitment Status : Not yet recruiting
First Posted : June 18, 2021
Last Update Posted : June 18, 2021
|Condition or disease||Intervention/treatment|
|Interstitial Lung Disease COPD Cystic Fibrosis Pulmonary Fibrosis Pulmonary Arterial Hypertension Emphysema||Device: LungGuard|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Global Utilization and Registry Database for Improved Preservation of Donor Lungs|
|Estimated Study Start Date :||June 15, 2021|
|Estimated Primary Completion Date :||June 15, 2023|
|Estimated Study Completion Date :||December 30, 2023|
Patients whose donor lung(s) was transported with the 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.
Standard Transport Patients
Patients whose donor lung(s) was transported with a method other than the LungGuard
- Number of subjects with Primary Graft Dysfunction (PGD) [ Time Frame: Post-transplant through 1 year post ]The number of subjects that develop PGD after transplant
- Number of subjects with rejection [ Time Frame: Post-transplant through 1 year post ]Subjects that show signs to rejection after transplant
- Survival [ Time Frame: Post-transplant through 1 year post ]patient survival post-transplant
- ICU Length of Stay [ Time Frame: Transplant through 1 year post-transplant ]Days the subject spent the ICU post-transplant
- Hospital Length of Stay [ Time Frame: Transplant through 1 year post-transplant ]Days the subject was in the hospital in total after transplant
- Number of rehospitalizations [ Time Frame: post-transplant through 1 year ]The number of times the subject was readmitted to the hospital after discharged post-transplant
- How long subjects needed mechanical support [ Time Frame: pre-transplant through 48 hours post-transplant ]Amount of time (minutes) mechanical support (EMCO and ventilator) was needed pre and post transplant
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04930289
|Contact: Julia Hersum||7814284153 ext email@example.com|
|Contact: Chris Tomosivitchfirstname.lastname@example.org|
|United States, North Carolina|
|Duke Lung Transplant Clinic|
|Durham, North Carolina, United States, 27710|
|Contact: Sarah Casalinova 919-613-5621 email@example.com|
|Principal Investigator: Matthew Hartwig, MD|
|Principal Investigator:||Matthew Hartwig, MD||Duke University|