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

March 7, 2024 updated by: Paragonix Technologies

Global Utilization and Registry Database for Improved Preservation of Donor Lungs

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

Study Overview

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

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Leuven, Belgium, 3000
        • University Hospitals Leuven
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Lung Transplant Clinic
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Scott & White Research Institute
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Primary lung transplant candidates at centers that use the LungGuard device

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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

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
The number of subjects that develop PGD after transplant
Post-transplant through 1 year post
Number of subjects with rejection
Time Frame: Post-transplant through 1 year post
Subjects that show signs to rejection after transplant
Post-transplant through 1 year post
Survival
Time Frame: Post-transplant through 1 year post
patient survival post-transplant
Post-transplant through 1 year post
ICU Length of Stay
Time Frame: Transplant through 1 year post-transplant
Days the subject spent the ICU post-transplant
Transplant through 1 year 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
Transplant through 1 year post-transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
post-transplant through 1 year
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
pre-transplant through 48 hours post-transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Matthew Hartwig, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2021

Primary Completion (Estimated)

June 15, 2024

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

June 9, 2021

First Submitted That Met QC Criteria

June 15, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

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

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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