COPD, Cystic Fibrosis, Emphysema, Interstitial Lung Disease, Pulmonary Arterial Hypertension, Pulmonary Fibrosis
Conditions
Brief summary
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
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 3,500 male and female subjects (including pediatric patients) meeting the study inclusion and exclusion criteria will be enrolled into the study at about 25 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.
Interventions
DEVICELungGuard
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.
DEVICEBAROGuard
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.
Sponsors
Paragonix Technologies
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with Primary Graft Dysfunction (PGD) | Post-transplant through 5 years post | The number of subjects that develop PGD after transplant |
| Number of subjects with rejection | Post-transplant through 5 years post | Subjects that show signs to rejection after transplant |
| Survival | Post-transplant through 5 years post | patient survival post-transplant |
| ICU Length of Stay | Transplant through 5 years post-transplant | Days the subject spent the ICU post-transplant |
| Hospital Length of Stay | Transplant through 5 years post-transplant | Days the subject was in the hospital in total after transplant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of rehospitalizations | 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 | pre-transplant through 48 hours post-transplant | Amount of time (minutes) mechanical support (EMCO and ventilator) was needed pre and post transplant |
Countries
Belgium, United States
Contacts
PRINCIPAL_INVESTIGATORMatthew Hartwig, MD
Duke University
Outcome results
None listed