Trials / Terminated
TerminatedNCT01241942
Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- University of North Carolina, Chapel Hill · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Emphysema
- Chronic Obstructive Pulmonary Disease (COPD)
- Cystic Fibrosis
- Pulmonary Fibrosis
- Bronchiectasis
- Sarcoidosis
- Pulmonary Hypertension
- Alpha-1 Antitrypsin Deficiency
Interventions
| Type | Name | Description |
|---|---|---|
| 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 UNC Hospitals (UNCH) where they will have an ex-vivo CT scan. Lungs determined suitable will be offered to consented patients at UNCH 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. |
| OTHER | Conventional Lung Transplant | No experimental procedures will be carried out. Lungs from conventional brain-dead organ donors will be used for transplant. |
Timeline
- Start date
- 2010-12-01
- Primary completion
- 2012-12-01
- Completion
- 2013-03-01
- First posted
- 2010-11-16
- Last updated
- 2018-07-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01241942. Inclusion in this directory is not an endorsement.