Study Description
The objective of this study is to evaluate the safety and effectiveness of the Centralized Lung Evaluation System (CLES) in enabling evaluation of potential donor lungs not otherwise used for transplant into subjects with end-stage, survival-limiting lung disease in need of lung transplantation. This will be accomplished by evaluating subject survival at the later of 12 months or hospital discharge after transplant.
ClinicalTrials.gov
Identifier:
NCT 03641677
For additional information, please visit
https://clinicaltrials.gov/ct2/show/NCT03641677
Study Design
16
TRANSPLANT
CENTER STUDY
SITES
150 patients
EVLP Group
75
Control Group
75
Study Objectives
Primary Endpoint
Secondary ENDPOINTs
Subject survival at
30 Days
90 Days
6 Months
Primary Graft Dysfunction (PGD) score (grades 0-3) measured at
0 HR
24 hr
48 hr
72 hr
Post-transplant
Time to first extubation
Rate of ECMO use post-transplant
ICU Length Of Stay (LOS)
Hospital LOS
Rate of Chronic Lung Allograft Dysfunction (CLAD)
Rate of respiratory failure
FEV₁ values at follow-up visits
Assessment of adverse events
Data will also be collected on patients who receive a conventional lung transplant. These patients will be enrolled in a contemporaneous control group in order to provide context for EVLP results.
Utilization rate
Increase in use of donor lungs
total Preservation time (TPT)
What is CLES?
The objective of the study is to evaluate the safety and effectiveness of the Centralized Lung Evaluation System (CLES) in enabling evaluation of potential donor lungs not otherwise used for transplant into subjects with end-stage, survival-limiting lung disease in need of transplantation.