Decreasing Edema With a Novel OCS Solution Trial

About

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

N/A

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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.

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