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

Sponsor

Paragonix Technologies (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04930289

Collaborator

(none)

500

Enrollment

Location

26.5

Anticipated Duration (Months)

18.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Interstitial Lung Disease COPD Cystic Fibrosis Pulmonary Fibrosis Pulmonary Arterial Hypertension Emphysema	Device: LungGuard

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Global Utilization and Registry Database for Improved Preservation of Donor Lungs

Actual Study Start Date :

Oct 15, 2021

Anticipated Primary Completion Date :

Jun 15, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
LungGuard patients Patients whose donor lung(s) was transported with the LungGuard device.	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.
Standard Transport Patients Patients whose donor lung(s) was transported with a method other than the LungGuard

Arm

Intervention/Treatment

LungGuard patients

Patients whose donor lung(s) was transported with the LungGuard device.

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.

Standard Transport Patients

Patients whose donor lung(s) was transported with a method other than the LungGuard

Outcome Measures

Primary Outcome 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 rejection [Post-transplant through 1 year post]
Subjects that show signs to rejection after transplant
Survival [Post-transplant through 1 year post]
patient survival post-transplant
ICU Length of Stay [Transplant through 1 year post-transplant]
Days the subject spent the ICU post-transplant
Hospital Length of Stay [Transplant through 1 year post-transplant]
Days the subject was in the hospital in total after transplant

Secondary Outcome Measures

Number of rehospitalizations [post-transplant through 1 year]
The number of times the subject was readmitted to the hospital after discharged post-transplant
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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