Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Primary Lung Graft Dysfunction (PGD)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 transplant at UNC or Duke
- •Male or Female, 15 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.
排除标准
- •Recipient fails to meet standard of care requirements for lung transplant, or decides not to participate.
研究组 & 干预措施
Ex-vivo lung perfusion (EVLP) with STEEN Solution™
The perfusion of the lungs will be performed using STEEN Solution™. The lungs will be physiologically assessed during ex vivo perfusion with STEEN Solution™ perfusate.
干预措施: Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ (Procedure)
Ex-vivo lung perfusion (EVLP) with STEEN Solution™
The perfusion of the lungs will be performed using STEEN Solution™. The lungs will be physiologically assessed during ex vivo perfusion with STEEN Solution™ perfusate.
干预措施: STEEN Solution™ (Device)
Lung transplant from conventional brain-dead organ donor
No experimental procedures will be carried out.
结局指标
主要结局
Primary Lung Graft Dysfunction (PGD)
时间窗: 24 and 72 hours
Primary Lung Graft Dysfunction (PGD) is an indicator for significant morbidity and mortality after lung transplantation. Grade 0: PaO2/FIO2 \> 300 with normal chest radiograph; Grade 1: PaO2/FIO2 \> 300 with diffuse infiltrates on the chest radiograph; Grade 2: PaO2/FIO2 between 200 and 300; Grade 3: PaO2/FIO2 \< 200.
30 Day Mortality and Graft Survival
时间窗: 30 Days
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.
次要结局
- ICU Length of Stay(Time to Discharge, up to 30 days)
- Day 7 Ventilator/ECMO Status(7 Days Post Transplant.)
- Bronchiolitis Obliterans Syndrome (BOS) Free Graft Survival(12 Months)
- Recipient Mortality at 12 Months(12 months)