N/A
N=24
Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability
Emphysema · Chronic Obstructive Pulmonary Disease (COPD) · Cystic Fibrosis · Pulmonary Fibrosis · Bronchiectasis
Bottom Line
View on ClinicalTrials.gov: NCT01615484 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: 30 Day Mortality and Graft Survival — 0; 22; 0; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ (Procedure); STEEN Solution™ (Device)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 30 Day Mortality and Graft Survival |
0; 22; 0; 2 | — |
| PRIMARY Primary Lung Graft Dysfunction (PGD) |
0; 5; 0; 9; 0; 6 | — |
| SECONDARY ICU Length of Stay |
6.91 | — |
| SECONDARY Day 7 Ventilator/ECMO Status |
4; 1; 19 | — |
| SECONDARY Recipient Mortality at 12 Months |
19; 5 | — |
| SECONDARY Bronchiolitis Obliterans Syndrome (BOS) Free Graft Survival |
17; 2 | — |
Summary
The purpose of this research study is to learn about the safety of transplanting lungs obtained from non-heart-beating donors (NHBDs) 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 perfusion and ventilation is to learn how well the lungs work, and whether they are likely safe to transplant.
Eligibility Criteria
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 transplant at UNC or Duke
- Male or Female, 15 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.
Exclusion Criteria
•Recipient fails to meet standard of care requirements for lung transplant, or decides not to participate.
Data sourced from ClinicalTrials.gov (NCT01615484). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.