Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs

Cystic Fibrosis Clinical Trial

— GUARDIANLUNG  

Official title:

Global Utilization and Registry Database for Improved Preservation of Donor Lungs

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04930289
• Other study ID #: PGX-004
• Status: Enrolling by invitation
• Start date: October 15, 2021
• Est. completion date: December 30, 2025

Study information

• Verified date: March 2024
• Source: Paragonix Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: December 30, 2025
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Cystic Fibrosis
• Emphysema
• Fibrosis
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Arterial Hypertension
• Pulmonary Fibrosis

Intervention

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.

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven
United States	Johns Hopkins University	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	Baylor Scott & White Research Institute	Dallas	Texas
United States	Duke Lung Transplant Clinic	Durham	North Carolina
United States	Houston Methodist Hospital	Houston	Texas
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Paragonix Technologies

Countries where clinical trial is conducted

United States,  Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with Primary Graft Dysfunction (PGD)	The number of subjects that develop PGD after transplant	Post-transplant through 1 year post
Primary	Number of subjects with rejection	Subjects that show signs to rejection after transplant	Post-transplant through 1 year post
Primary	Survival	patient survival post-transplant	Post-transplant through 1 year post
Primary	ICU Length of Stay	Days the subject spent the ICU post-transplant	Transplant through 1 year post-transplant
Primary	Hospital Length of Stay	Days the subject was in the hospital in total after transplant	Transplant through 1 year post-transplant
Secondary	Number of rehospitalizations	The number of times the subject was readmitted to the hospital after discharged post-transplant	post-transplant through 1 year
Secondary	How long subjects needed mechanical support	Amount of time (minutes) mechanical support (EMCO and ventilator) was needed pre and post transplant	pre-transplant through 48 hours post-transplant