Global Utilization and Registry Database for Improved Preservation of Donor Lungs
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Interstitial Lung Disease
- Sponsor
- Paragonix Technologies
- Enrollment
- 2000
- Locations
- 15
- Primary Endpoint
- Number of subjects with rejection
- Status
- Enrolling By Invitation
- Last Updated
- 11 months ago
Overview
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 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of subjects with rejection
Time Frame: Post-transplant through 1 year post
Subjects that show signs to rejection after transplant
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
Survival
Time Frame: Post-transplant through 1 year post
patient survival 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
ICU Length of Stay
Time Frame: Transplant through 1 year post-transplant
Days the subject spent the ICU post-transplant
Secondary Outcomes
- How long subjects needed mechanical support(pre-transplant through 48 hours post-transplant)
- Number of rehospitalizations(post-transplant through 1 year)