Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability

Descriptive Information
Brief Title † Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability
Official Title † Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability
Brief 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.
Detailed Description
Study Phase Phase 2
Study Type † Interventional
Study Design † Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † 30 Day Mortality and Graft Survival
Secondary Outcome Measure † ICU Length of Stay
Condition † Emphysema Chronic Obstructive Pulmonary Disease (COPD) Cystic Fibrosis Pulmonary Fibrosis Bronchiectasis Sarcoidosis Pulmonary Hypertension Alpha-1 Antitrypsin Deficiency
Intervention † ProcedureTransplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™
Study Arms / Comparison Groups Ex-vivo lung perfusion with STEEN Solution™ The perfusion of the lungs will be performed using STEEN Solution™. The lungs will be physiologically assessed during ex vivo perfusion with STEEN Solution™ perfusate. Lung transplant from conventional brain-dead organ donor No experimental procedures will be carried out.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Procedure
Estimated Enrollment † 10
Start Date † September 2013
Completion Date July 2018
Primary Completion Date July 2017
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.
Gender Both
Ages 15 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Thomas M Egan, MD, MSc, FACS, 919-966-3381,
Location Countries † United States
Administrative Information
NCT ID † NCT01615484
Organization ID UNC-002 Vitrolife
Secondary IDs †† 1UM1HL113115-01A1
Responsible Party Principal Investigator
Study Sponsor † University of North Carolina, Chapel Hill
Collaborators †† Duke University
Investigators † Principal Investigator: Thomas M. Egan, MD, MSc., UNC-Chapel Hill
Information Provided By
Verification Date July 2015
First Received Date † June 6, 2012
Last Updated Date July 21, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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