Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Emphysema
- 发起方
- University of North Carolina, Chapel Hill
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- 30 Day Mortality
- 状态
- 终止
- 最后更新
- 7年前
概览
简要总结
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.
研究者
入排标准
入选标准
- •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
排除标准
- •Recipient fails to meet standard of care requirements for lung transplant, or decides not to participate.
结局指标
主要结局
30 Day Mortality
时间窗: 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.
次要结局
- Primary Lung Graft Dysfunction (PGD)(24 and 72 hours post transplant.)
- Day 7 Ventilator/ECMO Status(7 Days Post Transplant.)
- ICU Length of Stay(Time to Discharge.)
- Recipient mortality at 12 months.(12 months)