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Observational Study of Lung Preservation for Transplant

This study, called GUARDIAN-Lung, is looking at how well donor lungs are preserved and transported for transplant. Researchers are comparing two methods: the LUNGguard and BAROguard systems, which are devices used to keep lungs cold during transport, against standard care methods. You might be able to join if you are a lung transplant candidate, including children, and your donor lungs meet your institution's requirements. The study will look at how many people experience primary graft dysfunction (problems with the new lung right after transplant), rejection, and how long people survive after transplant, for up to one year. This is an observational study, meaning researchers are collecting information from medical records of people who have already had transplants or are about to receive one.

Study design
This is an observational study collecting data from medical records. It aims to enroll about 2000 participants, including adults and children, at multiple clinical sites.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to one year after their transplant to assess outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04930289

Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs

Enrolling by Invitation
Not specifiedAll AgesObservational
Paragonix Technologies
~2,000 participants
Updated 2025-05-15 on ClinicalTrials.gov
What's tested:LungGuardBAROGuard

At a glance

Recruiting sites
0 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of subjects with Primary Graft Dysfunction (PGD)
Measured over Post-transplant through 1 year post
+4 more outcomes measured

Conditions

Interstitial Lung Disease
COPD
Cystic Fibrosis
Pulmonary Fibrosis
Pulmonary Arterial Hypertension
Emphysema

Explore related trials

Chronic Obstructive Pulmonary DiseaseCystic FibrosisEmphysemaInterstitial Lung DiseasePulmonary Arterial HypertensionPulmonary Fibrosis

Where it's being run

15 sites across 11 states
Texas3
California2
Pennsylvania2
Arizona1
Florida1
Maryland1
Massachusetts1
New York1

Study leadership

  • Matthew Hartwig, MD · PRINCIPAL_INVESTIGATOR · Duke University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of subjects with Primary Graft Dysfunction (PGD)Post-transplant through 1 year post

    The number of subjects that develop PGD after transplant

  • Number of subjects with rejectionPost-transplant through 1 year post

    Subjects that show signs to rejection after transplant

  • SurvivalPost-transplant through 1 year post

    patient survival post-transplant

  • ICU Length of StayTransplant through 1 year post-transplant

    Days the subject spent the ICU post-transplant

  • Hospital Length of StayTransplant through 1 year post-transplant

    Days the subject was in the hospital in total after transplant