Decreasing Edema With a Novel OCS Solution Trial (DENOVO)
Status
Conditions
Treatments
Details and patient eligibility
About
This is a prospective, multicenter randomized trial of lung transplant recipients transplanted with either a DBD or DCD donor lungs. The DENOVO Trial will enroll a total of 300 patients in the OCS arm and 150 patients in the SCS arm. The primary endpoint will be patient & graft survival and freedom of Primary Graft Dysfunction (PGD) grade 3 within the initial 72 hours post-transplantation.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Donor Inclusion/Exclusion Criteria
Inclusion Criteria:
- Donor lungs are deemed clinically acceptable for transplantation after physical examination of the donor lungs in the donor and/or on the back table in the donor operating room.
- Eligible for randomization to OCS or SCS treatment arms.
Exclusion Criteria:
- Severe traumatic donor lung injury with air and/or blood leak (as seen on radiological studies, bronchial examinations or final visual physical assessment in donor's chest or back table).
Recipient Inclusion/Exclusion:
Inclusion Criteria:
- Signed informed consent document and authorization to use and disclose protected health information
- Double lung transplant candidate
- Age ≥ 18 years old
Exclusion:
- Participant in any other interventional clinical or investigational trials/programs that may confound the outcomes of this trial.
Trial design
Primary purpose
Allocation
Interventional model
Masking
450 participants in 2 patient groups
Trial contacts and locations
Loading...
Central trial contact
Kelly Jork; Julia Church
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal