Trial to Evaluate the Safety and Effectiveness of the Portable Organ Care System (OCS™) Lung System for Recruiting, Preserving and Assessing Non-Ideal Donor Lungs for Transplantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- TransMedics
- Enrollment
- 46
- Locations
- 28
- Primary Endpoint
- Donor Lung Utilization Rate
Study Overview
Brief Summary
To evaluate the safety and effectiveness of the OCS™ Lung System to recruit, preserve and assess non-ideal donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.
Detailed Description
Inclusion
At least one of the following:
- Donor PaO2/FiO2 ≤ 300 mmHg at the time of the offer; or
- Expected cross-clamp time > 6 hours for the second lung; or
- Donor after Cardiac Death (DCD donor); or
- Donor age ≥ 55 years old
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female primary double lung transplant candidate
- •Age ≥ 18 years old
- •Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information
Exclusion Criteria
- •Prior solid organ or bone marrow transplant
- •Single lung recipient
- •Chronic use of hemodialysis or renal replacement therapy for diagnosis of chronic renal dysfunction requiring dialysis
- •Participant in any other clinical or investigational trials/programs
Arms & Interventions
OCS Preservation
Intervention: OCS Lung Preservation (Device)
Outcomes
Primary Outcomes
Donor Lung Utilization Rate
Time Frame: Immediately at Transplantation
Donor lung utilization rate, defined as the number of donated lungs instrumented on OCS™ that meet inclusion/exclusion criteria for the trial and acceptance criteria for transplantation after OCS™ Lung assessment divided by the total eligible donor lungs instrumented on the OCS™ Lung System.
Patient Survival
Time Frame: 30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant
Patient survival at Day-30 post-transplantation or initial hospital discharge post-transplantation, whichever occurs later.
Secondary Outcomes
- Primary Graft Dysfunction Grade 3(72 hours post-transplant)