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NCT01615484 · ClinicalTrials.gov registry record · NA
Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability
A NA study of Cystic Fibrosis and Pulmonary Hypertension, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
- 2
- Study locations
NCT01615484: Completed NA study of Cystic Fibrosis and Pulmonary Hypertension, sponsored by University of North Carolina, Chapel Hill.
NCT01615484 is a NA study of Cystic Fibrosis and Pulmonary Hypertension that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 24 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (87% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01615484, a NA study of Cystic Fibrosis and Pulmonary Hypertension, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™
- DEVICE STEEN Solution™
Study Locations (2)
North Carolina
- UNC-Chapel Hill - Chapel Hill
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2013-09 |
| Est. Completion | 2017-01 |
| Phase | NA |
What the finished NCT01615484 record still lists
NCT01615484 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (87% lower).
The record links to 8 conditions, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ is the first listed.
NCT01615484 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01615484 about?
NCT01615484 is a clinical study titled "Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability". 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 Vitr...
What is the current status of trial NCT01615484?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2013-09. Estimated completion is 2017-01.
What conditions does trial NCT01615484 study?
This clinical trial studies the following conditions: Cystic Fibrosis, Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease (COPD), Emphysema, Alpha-1 Antitrypsin Deficiency.
What interventions are being tested in trial NCT01615484?
The interventions under investigation include: Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ (PROCEDURE), STEEN Solution™ (DEVICE).
Who is sponsoring clinical trial NCT01615484?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01615484 being conducted?
This trial has 2 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01615484's enrollment target sits among peer trials
24 123rd of 169 higher than 45 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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