Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- 30 Day Mortality
Study Overview
Brief Summary
The purpose of this research study is to perfect the technique of EVLP and learn about the safety of transplanting lungs that have been ventilated (attached to a breathing machine or ventilator to deliver oxygen) and perfused with a lung perfusion solution (Steen solution™, made by Vitrolife). This ventilation and perfusion will be done outside the body (ex-vivo) in a modified cardiopulmonary bypass circuit (the kind of device used routinely during most heart surgeries). The purpose of performing ex-vivo lung perfusion and ventilation (EVLP) is to learn how well the lungs work, and whether they are likely safe to transplant.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Lung Recipient Inclusion Criteria:
- •A recipient must meet the following requirement to enroll into the study:
- •Requires a single or bilateral lung transplant and is listed for lung transplant at UNC.
- •Male or Female, 18 years of age or older.
- •Subject or Subject's Representative provides a legally effective informed consent.
- •Recipient does not have HIV, active Hepatitis or is colonized with Burkholderia cepacia.
- •Potential subjects who have undergone previous lung transplants and meet all other inclusion criteria are eligible for study participation.
- •Lung Recipient
Exclusion Criteria
- •Recipient fails to meet standard of care requirements for lung transplant, or decides not to participate.
Arms & Interventions
EVLP with STEEN Solution™
The perfusion of the lungs will be performed using STEEN Solution™ and then physiologically assessed. Lungs deemed suitable will be transplanted after Ex-vivo Perfusion w/ STEEN Solution™.
Intervention: Steen Solution™ (Device)
Conventional Lung transplant
No experimental procedures will be carried out. Lungs from conventional brain-dead organ donors will be used for transplant.
Intervention: Conventional Lung Transplant (Other)
Outcomes
Primary Outcomes
30 Day Mortality
Time Frame: 30 Days
The primary objective evaluated for this study is recipient mortality at 30 days post transplant. 30 day mortality is used as a standard research assessment to evaluate post transplant outcomes.
Secondary Outcomes
- Primary Lung Graft Dysfunction (PGD)(24 and 72 hours post transplant.)
- Day 7 Ventilator/ECMO Status(7 Days Post Transplant.)
- ICU Length of Stay(Time to Discharge.)
- Recipient mortality at 12 months.(12 months)