Evaluation and Reconditioning of Marginal Lung Donors to Transplantation by ex Vivo Lung Perfusion
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Respiratory complications (primary graft dysfunction, infection, rejection, bronchiolitis obliterates syndrome)
研究概览
简要总结
Only about 15% of the potential candidates for lung donation are considered suitable for transplantation. A new method for ex vivo lung perfusion (EVLP) has been developed and can be used for evaluation and reconditioning of "marginal" and unacceptable lungs. The ´purpose of this study is to analyse the executability and safety of ex vivo lung perfusion pulmonary ex vivo in marginal donors.
详细描述
Donor Inclusion criteria:
- Age < 55 years-old;
- Smoking history < 20 pack-year;
- Clear chest radiograph;
- Absence of significant chest trauma;
- Absence of purulent secretions and gastric contents at bronchoscopy;
- PaO2 < 300 mm Hg (FIO2 1.0, PEEP 5 cmH2O)
Exclusion criteria:
- Lungs presenting PO2 < 400 mmHg after ex vivo lung perfusion
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age < 55 years-old;
- •Smoking history < 20 pack-year;
- •Clear chest radiograph;
- •Absence of significant chest trauma;
- •Absence of purulent secretions and gastric contents at bronchoscopy;
- •PaO2 < 300 mm Hg (FIO2 1.0, PEEP 5 cmH2O)
排除标准
- •Lungs presenting PO2 < 400 mmHg after ex vivo lung perfusion
研究组 & 干预措施
Ex vivo lung transplantation
single-group studies
干预措施: Ex vivo lung transplantation (Procedure)
结局指标
主要结局
Respiratory complications (primary graft dysfunction, infection, rejection, bronchiolitis obliterates syndrome)
时间窗: 30 days after the ex vivo lung transplantation
30-days mortality
时间窗: 30 days after ex vivo lung transplantation
12-months survival
时间窗: 12 months survival after ex vivo lung transplantation
次要结局
- Non-respiratory complications (arrhythmia, renal failure, sepsis)(30 days after ex vivo lung transplantation)
- Oxygenation index (PaO2/FiO2)on ICU arrival and 72 hours(72 hours after ex vivo lung transplantation)
- Hospital and ICU time of stay(12 months after ex vivo lung transplantation)
- Mechanical ventilation time(30 days after ex vivo lung transplantation)