- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04930289
Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs (GUARDIANLUNG)
Global Utilization and Registry Database for Improved Preservation of Donor Lungs
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
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Leuven, Belgium, 3000
- University Hospitals Leuven
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-
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California
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San Francisco, California, United States, 94143
- University of California, San Francisco
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Maryland
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Baltimore, Maryland, United States, 21218
- Johns Hopkins University
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Lung Transplant Clinic
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center
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Texas
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Dallas, Texas, United States, 75246
- Baylor Scott & White Research Institute
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Houston, Texas, United States, 77030
- Houston Methodist Hospital
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
LungGuard patients
Patients whose donor lung(s) was transported with the LungGuard device.
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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.
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Standard Transport Patients
Patients whose donor lung(s) was transported with a method other than the LungGuard
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects with Primary Graft Dysfunction (PGD)
Time Frame: Post-transplant through 1 year post
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The number of subjects that develop PGD after transplant
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Post-transplant through 1 year post
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Number of subjects with rejection
Time Frame: Post-transplant through 1 year post
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Subjects that show signs to rejection after transplant
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Post-transplant through 1 year post
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Survival
Time Frame: Post-transplant through 1 year post
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patient survival post-transplant
|
Post-transplant through 1 year post
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ICU Length of Stay
Time Frame: Transplant through 1 year post-transplant
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Days the subject spent the ICU post-transplant
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Transplant through 1 year post-transplant
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Hospital Length of Stay
Time Frame: Transplant through 1 year post-transplant
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Days the subject was in the hospital in total after transplant
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Transplant through 1 year post-transplant
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of rehospitalizations
Time Frame: post-transplant through 1 year
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The number of times the subject was readmitted to the hospital after discharged post-transplant
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post-transplant through 1 year
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How long subjects needed mechanical support
Time Frame: pre-transplant through 48 hours post-transplant
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Amount of time (minutes) mechanical support (EMCO and ventilator) was needed pre and post transplant
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pre-transplant through 48 hours post-transplant
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Matthew Hartwig, MD, Duke University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PGX-004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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