Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability
| Status: | Completed |
|---|---|
| Conditions: | Bronchitis, Chronic Obstructive Pulmonary Disease, High Blood Pressure (Hypertension), Endocrine, Pulmonary |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 15 - Any |
| Updated: | 6/10/2018 |
| Start Date: | September 2013 |
| End Date: | January 2017 |
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.
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.
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.
We found this trial at
2
sites
CHapel Hill, North Carolina 27599
Principal Investigator: Thomas M. Egan, MD, MSc.
Phone: 919-966-3381
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