Clinical trial NCT04930289: Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs
Official title: Global Utilization and Registry Database for Improved Preservation of Donor Lungs
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Interstitial Lung Disease
COPD
Cystic Fibrosis
Pulmonary Fibrosis
Pulmonary Arterial Hypertension
Emphysema
Lead sponsor: Paragonix Technologies
Sponsor class: INDUSTRY
First posted: 2021-06-18
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary lung transplant candidates at centers that use the LungGuard device

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.

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

Primary outcomes:
measure: Number of subjects with Primary Graft Dysfunction (PGD)
timeFrame: Post-transplant through 1 year post
measure: Number of subjects with rejection
timeFrame: Post-transplant through 1 year post
measure: Survival
timeFrame: Post-transplant through 1 year post
measure: ICU Length of Stay
timeFrame: Transplant through 1 year post-transplant
measure: Hospital Length of Stay
timeFrame: Transplant through 1 year post-transplant
Secondary outcomes:
measure: Number of rehospitalizations
timeFrame: post-transplant through 1 year
measure: How long subjects needed mechanical support
timeFrame: pre-transplant through 48 hours post-transplant
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Stanford
country: United States
facility: Stanford Medicine
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Bronx
country: United States
facility: Montefiore Hospital
state: New York
city: Durham
country: United States
facility: Duke Lung Transplant Clinic
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Duke University
name: Matthew Hartwig, MD
role: PRINCIPAL_INVESTIGATOR
References: