Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability

Not Applicable

Terminated

• Conditions: Cystic Fibrosis; Pulmonary Fibrosis; Alpha-1 Antitrypsin Deficiency; Sarcoidosis; Emphysema; Chronic Obstructive Pulmonary Disease (COPD); Bronchiectasis; Pulmonary Hypertension
• Interventions: Other: Conventional Lung Transplant; Device: Steen Solution™

• Registration Number: NCT01241942
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

The purpose of this research study is to perfect the technique of EVLP and learn about the safety of transplanting lungs 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 lung perfusion and ventilation (EVLP) is to learn how well the lungs work, and whether they are likely safe to transplant.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-12
• Study First Submitted QC: 2010-11-15
• Study First Posted: 2010-11-16
• Study Start: 2010-12
• Primary Completion: 2012-12
• Study Completion: 2013-03
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-11
• Last Update Posted: 2018-07-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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 lung transplant at UNC.
• Male or Female, 18 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.

Lung Recipient

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Exclusion Criteria

• Recipient fails to meet standard of care requirements for lung transplant, or decides not to participate.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Conventional Lung transplant	Conventional Lung Transplant	No experimental procedures will be carried out. Lungs from conventional brain-dead organ donors will be used for transplant.
EVLP with STEEN Solution™	Steen Solution™	The perfusion of the lungs will be performed using STEEN Solution™ and then physiologically assessed. Lungs deemed suitable will be transplanted after Ex-vivo Perfusion w/ STEEN Solution™.

Primary Outcome Measures

Name	Time	Method
30 Day Mortality	30 Days	The primary objective evaluated for this study is recipient mortality at 30 days post transplant. 30 day mortality is used as a standard research assessment to evaluate post transplant outcomes.

Secondary Outcome Measures

Name	Time	Method
Primary Lung Graft Dysfunction (PGD)	24 and 72 hours post transplant.	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.; \* partial pressure of oxygen in the arterial blood (PaO2); \*\* fraction of inspired oxygen inspired oxygen fraction (FIO2)
Day 7 Ventilator/ECMO Status	7 Days Post Transplant.	7 days ventilator or extra-corporeal membrane oxygenator (ECMO free are being evaluated as secondary objectives.
ICU Length of Stay	Time to Discharge.	The length of ICU stay is another standard research and clinical outcome assessment post transplant and has been selected as a secondary objective.
Recipient mortality at 12 months.	12 months	Recipient mortality at 12 months post transplant is being evaluated as a secondary objective.

Trial Locations

Locations (1)

UNC Hospitals; 🇺🇸 Chapel Hill, North Carolina, United States