Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability
Completed · Not applicable
Conditions studied: Emphysema, Chronic Obstructive Pulmonary Disease (COPD), Cystic Fibrosis, Pulmonary Fibrosis, Bronchiectasis, Sarcoidosis, Pulmonary Hypertension, Alpha-1 Antitrypsin Deficiency
In brief
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.
Key facts
- Study ID
- NCT01615484
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 24
- Starts
- 2013-09-01
- Expected to finish
- 2017-01-01
- Last updated by the study team
- 2018-06-08
Who can join
Age: 15 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Recipient fails to meet standard of care requirements for lung transplant, or decides not to participate.
Where it is running
- UNC-Chapel Hill — Chapel Hill, North Carolina, United States
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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