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Enrolling by Invitation

NCT Number: NCT04930289

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

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Key information

Conditions

Interstitial Lung Disease COPD Chronic Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Disease Attributes Emphysema Fibrosis Genetic Diseases, Inborn Hypertension, Pulmonary Infant, Newborn, Diseases Lung Diseases Lung Diseases, Interstitial Lung Diseases, Obstructive Pancreatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Arterial Hypertension Pulmonary Disease, Chronic Obstructive Pulmonary Fibrosis Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Leuven, Leuven, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

BAROGuard

Device

The BAROguard (the "System") is ultraportable hypothermic preservation and transport system intended for use with donor lungs. BAROguard is a legally marketed, FDA cleared medical device in the United States. The intended organ storage time for BAROguard™ is up to 8 hours.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Paragonix Technologies

Industry

Registry information

Acronym: GUARDIANLUNG

Important dates

Study start
2021
Primary completion
2028
Study completion
2029
First posted
Jun 18, 2021
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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