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

Not Applicable

Completed

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

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

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Ex-vivo lung perfusion (EVLP) with STEEN Solution™	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.
Ex-vivo lung perfusion (EVLP) with STEEN Solution™	Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ 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.

Primary Outcome Measures

Name	Time	Method
Primary Lung Graft Dysfunction (PGD)	24 and 72 hours	Primary Lung Graft Dysfunction (PGD) is an indicator for significant morbidity and mortality after lung transplantation. Grade 0: PaO2/FIO2 \> 300 with normal chest radiograph; Grade 1: PaO2/FIO2 \> 300 with diffuse infiltrates on the chest radiograph; Grade 2: PaO2/FIO2 between 200 and 300; Grade 3: PaO2/FIO2 \< 200.
30 Day Mortality and Graft Survival	30 Days	The primary objective evaluated for this study is recipient mortality and graft survival at 30 days post transplant. 30 day mortality and graft survival is used as a standard research assessment to evaluate post transplant outcomes.

Secondary Outcome Measures

Name	Time	Method
ICU Length of Stay	Time to Discharge, up to 30 days	The length of ICU stay in days is another standard research and clinical outcome assessment post transplant and has been selected as a secondary objective.
Day 7 Ventilator/ECMO Status	7 Days Post Transplant.	Participants' status at Day 7 defined as the following: mechanical ventilation, extra-corporeal membrane oxygenator (ECMO), or extubated.
Bronchiolitis Obliterans Syndrome (BOS) Free Graft Survival	12 Months	Bronchiolitis Obliterans Syndrome (BOS) free graft survival at 12 months is being used as a secondary outcome.
Recipient Mortality at 12 Months	12 months	Recipient mortality at 12 months post transplant is being evaluated as a secondary objective.

Locations (2): UNC-Chapel Hill
🇺🇸
Chapel Hill, North Carolina, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States