Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability
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ClinicalTrials.gov Identifier: NCT01241942 |
Recruitment Status
:
Terminated
(Funding exhausted.)
First Posted
: November 16, 2010
Last Update Posted
: February 6, 2017
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Condition or disease | Intervention/treatment | Phase |
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Emphysema Chronic Obstructive Pulmonary Disease (COPD) Cystic Fibrosis Pulmonary Fibrosis Bronchiectasis Sarcoidosis Pulmonary Hypertension Alpha-1 Antitrypsin Deficiency | Device: Steen Solution™ Other: Conventional Lung Transplant | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 103 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Device Feasibility |
Official Title: | Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability |
Study Start Date : | December 2010 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: EVLP with 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™.
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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. 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 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 with Steen Solution™ will be transplanted into recipients as per current clinical practice.
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Active Comparator: Conventional Lung transplant
No experimental procedures will be carried out. Lungs from conventional brain-dead organ donors will be used for transplant.
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Other: Conventional Lung Transplant
No experimental procedures will be carried out. Lungs from conventional brain-dead organ donors will be used for transplant.
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- 30 Day Mortality [ Time Frame: 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.
- Primary Lung Graft Dysfunction (PGD) [ Time Frame: 24 and 72 hours post transplant. ]Primary Lung Graft Dysfunction (PGD) is an indicator for significant morbidity and mortality after lung transplantation. PGD at 24 and 72 hours post LTX are secondary objectives.
- ICU Length of Stay [ Time Frame: 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.
- Day 7 Ventilator/ECMO Status [ Time Frame: 7 Days Post Transplant. ]7 days ventilator or extra-corporeal membrane oxygenator (ECMO free are being evaluated as secondary objectives.
- Recipient mortality at 12 months. [ Time Frame: 12 months ]Recipient mortality at 12 months post transplant is being evaluated as a secondary objective.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Lung Recipient 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 Exclusion Criteria:
- Recipient fails to meet standard of care requirements for lung transplant, or decides not to participate.

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): NCT01241942
United States, North Carolina | |
UNC Hospitals | |
Chapel Hill, North Carolina, United States, 27599 |
Principal Investigator: | Thomas M. Egan, MD, MSc. | UNC-Chapel Hill |
Publications:
Responsible Party: | University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT01241942 History of Changes |
Other Study ID Numbers: |
UNC-001 Vitrolife |
First Posted: | November 16, 2010 Key Record Dates |
Last Update Posted: | February 6, 2017 |
Last Verified: | July 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | Yes | |
Device Product Not Approved or Cleared by U.S. FDA: | No |
Keywords provided by University of North Carolina, Chapel Hill:
Lung Transplant Emphysema Chronic Obstructive Pulmonary Disease (COPD) Cystic Fibrosis Pulmonary Fibrosis |
Bronchiectasis Sarcoidosis Pulmonary Hypertension Alpha-1 Antitrypsin Deficiency |
Additional relevant MeSH terms:
Hypertension Lung Diseases Fibrosis Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Cystic Fibrosis Hypertension, Pulmonary Pulmonary Fibrosis Emphysema Pulmonary Emphysema Sarcoidosis Bronchiectasis Alpha 1-Antitrypsin Deficiency Vascular Diseases |
Cardiovascular Diseases Respiratory Tract Diseases Pathologic Processes Pancreatic Diseases Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lymphoproliferative Disorders Lymphatic Diseases Bronchial Diseases Liver Diseases Subcutaneous Emphysema Pharmaceutical Solutions |