Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs

• Conditions: COPD; Cystic Fibrosis; Emphysema; Pulmonary Arterial Hypertension; Interstitial Lung Disease; Pulmonary Fibrosis
• Interventions: Device: BAROGuard; Device: LungGuard

• Registration Number: NCT04930289
• Lead Sponsor: Paragonix Technologies

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.

Study Timeline

• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-15
• Study First Posted: 2021-06-18
• Study Start: 2021-10-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2028-06-15
• Study Completion: 2029-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BAROGuard Patients	BAROGuard	Patients whose donor lung(s) was transported with the BAROGuard device.
LungGuard patients	LungGuard	Patients whose donor lung(s) was transported with the LungGuard device.

Primary Outcome Measures

Name	Time	Method
Number of subjects with rejection	Post-transplant through 1 year post	Subjects that show signs to rejection after transplant
Number of subjects with Primary Graft Dysfunction (PGD)	Post-transplant through 1 year post	The number of subjects that develop PGD after transplant
Survival	Post-transplant through 1 year post	patient survival post-transplant
Hospital Length of Stay	Transplant through 1 year post-transplant	Days the subject was in the hospital in total after transplant
ICU Length of Stay	Transplant through 1 year post-transplant	Days the subject spent the ICU post-transplant

Secondary Outcome Measures

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

Trial Locations

Locations (15)

St. Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States

Stanford Medicine; 🇺🇸 Stanford, California, United States

Mayo Clinic Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Montefiore Hospital; 🇺🇸 Bronx, New York, United States

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

The University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Duke Lung Transplant Clinic; 🇺🇸 Durham, North Carolina, United States

Scroll for more (5 remaining)