Lung Transplant
Conditions
Brief summary
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.
Interventions
DEVICEOCS Lung System
Donor lungs preserved on OCS Lung System
OTHERStatic Cold Storage
Donor Lungs preserved on Static Cold Storage
Sponsors
TransMedics
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day patient and graft survival with freedom from PGD3 | 30-days post-transplant | The primary endpoint is 30-day patient and graft survival with freedom from PGD 3 within the initial 72-hours (T0-T72). |
Contacts
Primary ContactJulia Church
Backup ContactKelly Jork
Outcome results
None listed