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

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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.


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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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Phone: 919-681-5775
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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