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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Sponsor:
University of North Carolina, Chapel Hill
Collaborators:
Vitrolife
XVIVO Perfusion
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
Tracking Information | |||||||
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First Submitted Date ICMJE | November 12, 2010 | ||||||
First Posted Date ICMJE | November 16, 2010 | ||||||
Last Update Posted Date | February 6, 2017 | ||||||
Study Start Date ICMJE | December 2010 | ||||||
Actual Primary Completion Date | December 2012 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | Complete list of historical versions of study NCT01241942 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability | ||||||
Official Title ICMJE | Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability | ||||||
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 Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase | Not Applicable | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Device Feasibility |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Terminated | ||||||
Actual Enrollment ICMJE |
103 | ||||||
Original Estimated Enrollment ICMJE |
20 | ||||||
Actual Study Completion Date | June 2013 | ||||||
Actual Primary Completion Date | December 2012 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Lung Recipient Inclusion Criteria:
Lung Recipient Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01241942 | ||||||
Other Study ID Numbers ICMJE | UNC-001 Vitrolife | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | University of North Carolina, Chapel Hill | ||||||
Study Sponsor ICMJE | University of North Carolina, Chapel Hill | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of North Carolina, Chapel Hill | ||||||
Verification Date | July 2016 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |