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

University of North Carolina (UNC)

Status: Completed

Conditions: Pulmonary Fibrosis; Sarcoidosis; Bronchiectasis; Emphysema; Cystic Fibrosis; Pulmonary Hypertension; Chronic Obstructive Pulmonary Disease (COPD); Alpha-1 Antitrypsin Deficiency

Treatments: Device: STEEN Solution™; Procedure: Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT01615484

UNC-002 Vitrolife

1UM1HL113115-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Ex-vivo lung perfusion (EVLP) with STEEN Solution™

Experimental group

Description:

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.

Treatment:

Procedure: Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™

Device: STEEN Solution™

Lung transplant from conventional brain-dead organ donor

No Intervention group

Description:

No experimental procedures will be carried out.