Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability
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|ClinicalTrials.gov Identifier: NCT01615484|
Recruitment Status : Completed
First Posted : June 8, 2012
Results First Posted : April 20, 2018
Last Update Posted : June 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Emphysema Chronic Obstructive Pulmonary Disease (COPD) Cystic Fibrosis Pulmonary Fibrosis Bronchiectasis Sarcoidosis Pulmonary Hypertension Alpha-1 Antitrypsin Deficiency||Procedure: Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ Device: STEEN Solution™||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||January 2017|
Experimental: Ex-vivo lung perfusion (EVLP) 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.
Procedure: Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™
After EVLP, lungs will be cooled in the circuit to room temperature, then flushed with cold Perfadex™, and taken to UNCH where they will have an ex-vivo CT scan. Lungs determined suitable will be offered to consented patients at UNC Hospitals and Duke University Medical Center based on Lung Allocation Score. Lungs not considered for transplantation may be subjected to different experiments but are not to be a part of this research study. In summary, lungs with good and stable function during EVLP will be transplanted into recipients as per current clinical practice.
Device: STEEN Solution™
This solution is a buffered dextran and albumin-containing extracellular perfusate with an optimal colloid osmotic pressure developed specifically for extra-corporeal perfusion of lungs.
No Intervention: Lung transplant from conventional brain-dead organ donor
No experimental procedures will be carried out.
- 30 Day Mortality and Graft Survival [ Time Frame: 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.
- Primary Lung Graft Dysfunction (PGD) [ Time Frame: 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.
- ICU Length of Stay [ Time Frame: 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 [ Time Frame: 7 Days Post Transplant. ]Participants' status at Day 7 defined as the following: mechanical ventilation, extra-corporeal membrane oxygenator (ECMO), or extubated.
- Recipient Mortality at 12 Months [ Time Frame: 12 months ]Recipient mortality at 12 months post transplant is being evaluated as a secondary objective.
- Bronchiolitis Obliterans Syndrome (BOS) Free Graft Survival [ Time Frame: 12 Months ]Bronchiolitis Obliterans Syndrome (BOS) free graft survival at 12 months is being used as a secondary outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01615484
|United States, North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Thomas M. Egan, MD, MSc.||UNC-Chapel Hill|