Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs

N/AEnrolling By InvitationNCT04930289

Paragonix Technologies2,000 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

2,000

Conditions

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

Interventions

LungGuardDEVICE

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.

BAROGuardDEVICE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (15)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

University of California, San Francisco

San Francisco, California, United States

Outcomes

Primary Outcomes

Number of subjects with Primary Graft Dysfunction (PGD)

The number of subjects that develop PGD after transplant

Time frame: Post-transplant through 1 year post

Number of subjects with rejection

Subjects that show signs to rejection after transplant

Time frame: Post-transplant through 1 year post

Survival

patient survival post-transplant

Time frame: Post-transplant through 1 year post

ICU Length of Stay

Days the subject spent the ICU post-transplant

Time frame: Transplant through 1 year post-transplant

Hospital Length of Stay

Days the subject was in the hospital in total after transplant

Time frame: Transplant through 1 year post-transplant

Secondary Outcomes

Number of rehospitalizations

The number of times the subject was readmitted to the hospital after discharged post-transplant

Time frame: post-transplant through 1 year

How long subjects needed mechanical support

Amount of time (minutes) mechanical support (EMCO and ventilator) was needed pre and post transplant

Time frame: pre-transplant through 48 hours post-transplant

Data from ClinicalTrials.gov

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