Clinical Trial of Ex Vivo Lung Perfusion (EVLP) for the Reconditioning of Marginal Donor Lungs for Transplantation.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Measure of survival
研究概览
简要总结
The overall objective of this study is to evaluate the clinical effectiveness of the novel technique of donor EVLP in increasing lung transplant activity by allowing previously unusable donor lungs to be safely used in clinical lung transplantation. Furthermore, to utilize the EVLP technique in research settings thus allowing the evaluation of inflammatory molecules (biomarkers) that would benefit a successful pre-conditioning and increase knowledge of the lungs inflammatory response before transplantation.
详细描述
Human donor lungs that do not meet the standard clinical criteria for donor lung utilization but fit into the study inclusion criteria will be retrieved from the donor using current donor lung retrieval techniques. These lungs will be brought to the study transplant centre to be perfused in our system by the transplant team. Perfusion of these lungs will be performed using evaluation solution with addition of red blood cells cross matched with the recipient, heparin and antibiotics. Those lungs that after perfusion in our system meet the normal transplantation criteria will be considered for transplantation. Lungs will be excluded for transplantation if the organs don't meet the normal transplantation criteria.
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
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (aged 18 years and over).
- •Patients already on or added to the active waiting list for first lung transplant.
- •Patients providing informed consent for participation in the study at the time of study commencement or time of listing for transplant.
- •Patients' re-confirmation informed consent for the study on the day of the lung transplant.
排除标准
- •Patients aged less than 18 years.
- •Patients not providing informed consent for the study.
- •Patients not in possession of patient information sheets for the study prior to the day of lung transplant.
- •Patients' not re-confirming consent for the study on the day of lung transplant.
- •Patients requiring invasive mechanical ventilation, extracorporeal membrane oxygenation (ECMO) support.
结局指标
主要结局
Measure of survival
时间窗: 12 months after transplantation
To measure survival 12 months after transplantation in recipients of EVLP assessed and reconditioned donor lungs (treatment group), compared to that of recipients of standard donor lungs (control group), in order to assess whether survival in the EVLP treatment group over that period is non-inferior to that in the standard control group
次要结局
- Duration of hospital stay(Expected average of 6 weeks)
- Evaluate primary graft dysfunction (PGD)(6h, 12h, 24h, 48h and 72h post-transplant)
- 90 day Mortality(90 days after lung transplant)
- Duration of mechanical ventilation(30 days after lung transplant)
- Quality of life (QoL) questionnaire(The day that patients are added to transplant list, at 90 days and 1 year post transplantation)