Purpose of this Study
In this study, you will be placed into one of two groups by chance. One group will have donated lungs preserved using a special system called the OCS Lung System with a new solution. The other group will have the lungs preserved using the usual cold storage method. You will be followed from the time you agree to join the study until thirty days later or until you leave the hospital, whichever is longer. The study does not require any extra tests or visits. The study team will collect information from your medical records based on the care, tests, and procedures you already receive.
Who Can Participate?
Eligibility
Adults who are candidates for double lung transplantation
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is about a machine called the Organ Care System that keeps donor lungs healthy before a transplant. The machine lets doctors watch and care for the lungs while they are outside the body. A new liquid used in this machine was changed to help reduce extra fluid in the lungs. The goal of the study is to see if this new lung solution is safe and helps the lungs work better compared to the common way of keeping lungs cold on ice before transplant surgery.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
Decreasing Edema with a Novel OCS Solution (DENOVO) Trial
Principal Investigator
Matthew
Hartwig
Protocol Number
PRO00119843
Phase
N/A
Enrollment Status
Open to Enrollment