Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs (GUARDIANLUNG)

• ClinicalTrials.gov Identifier: NCT04930289
• Recruitment Status: Enrolling by invitation
• First Posted: June 18, 2021
• Last Update Posted: August 10, 2022
• Sponsor: Paragonix Technologies
• Information provided by (Responsible Party): Paragonix Technologies

Study Description

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

Condition or disease	Intervention/treatment
Interstitial Lung Disease; COPD; Cystic Fibrosis; Pulmonary Fibrosis; Pulmonary Arterial Hypertension; Emphysema	Device: LungGuard

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 Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Target Follow-Up Duration: 1 Year
• Official Title: Global Utilization and Registry Database for Improved Preservation of Donor Lungs
• Actual Study Start Date: October 15, 2021
• Estimated Primary Completion Date: June 15, 2023
• Estimated Study Completion Date: December 30, 2023

Groups and Cohorts

Group/Cohort	Intervention/treatment
LungGuard patients; Patients whose donor lung(s) was transported with the LungGuard device.	Device: LungGuard; 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.
Standard Transport Patients; Patients whose donor lung(s) was transported with a method other than the LungGuard

Outcome Measures

Primary Outcome Measures :

1. 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
2. Number of subjects with rejection [ Time Frame: Post-transplant through 1 year post ]
   Subjects that show signs to rejection after transplant
3. Survival [ Time Frame: Post-transplant through 1 year post ]
   patient survival post-transplant
4. ICU Length of Stay [ Time Frame: Transplant through 1 year post-transplant ]
   Days the subject spent the ICU post-transplant
5. Hospital Length of Stay [ Time Frame: Transplant through 1 year post-transplant ]
   Days the subject was in the hospital in total after transplant

Secondary Outcome Measures :

1. Number of rehospitalizations [ Time Frame: post-transplant through 1 year ]
   The number of times the subject was readmitted to the hospital after discharged post-transplant
2. How long subjects needed mechanical support [ Time Frame: pre-transplant through 48 hours post-transplant ]
   Amount of time (minutes) mechanical support (EMCO and ventilator) was needed pre and post transplant

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Primary lung transplant candidates at centers that use the LungGuard device

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

Contacts and Locations

Locations

United States, North Carolina

Duke Lung Transplant Clinic

Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Paragonix Technologies

Investigators

• Principal Investigator: Matthew Hartwig, MD; Duke University

More Information

• Responsible Party: Paragonix Technologies
• ClinicalTrials.gov Identifier: NCT04930289
• Other Study ID Numbers: PGX-004
• First Posted: June 18, 2021
• Last Update Posted: August 10, 2022
• Last Verified: August 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Cystic Fibrosis; Lung Diseases; Pulmonary Arterial Hypertension; Pulmonary Fibrosis; Lung Diseases, Interstitial; Fibrosis; Emphysema; Pathologic Processes; Pancreatic Diseases; Digestive System Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Hypertension, Pulmonary