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.
Study Type
OBSERVATIONAL
Enrollment
2,000
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.
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.
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
University of California, San Francisco
San Francisco, California, United States
Number of subjects with Primary Graft Dysfunction (PGD)
The number of subjects that develop PGD after transplant
Time frame: Post-transplant through 1 year post
Number of subjects with rejection
Subjects that show signs to rejection after transplant
Time frame: Post-transplant through 1 year post
Survival
patient survival post-transplant
Time frame: Post-transplant through 1 year post
ICU Length of Stay
Days the subject spent the ICU post-transplant
Time frame: Transplant through 1 year post-transplant
Hospital Length of Stay
Days the subject was in the hospital in total after transplant
Time frame: Transplant through 1 year post-transplant
Number of rehospitalizations
The number of times the subject was readmitted to the hospital after discharged post-transplant
Time frame: 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
Time frame: pre-transplant through 48 hours post-transplant
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Stanford Medicine
Stanford, California, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Montefiore Hospital
The Bronx, New York, United States
Duke Lung Transplant Clinic
Durham, North Carolina, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
...and 5 more locations