Comparison Between Two Medical Devices for the Reconditioning of Lung Grafts: Pilot Study EVOLUTION (Ex viVO Lung perfUsion for Lung Transplantation)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Acceptance rate to transplant
研究概览
简要总结
This study aims to evaluate the effectiveness of two medical devices ( XPS XVIVO and OCS Transmedics) used for organ reperfusion in patients needing bilateral lung transplants from marginal donors.
详细描述
Marginal organs, which do not have ideal transplant characteristics but are not rejected, can be treated with ex-vivo reperfusion and reventilation machines to optimize their condition. The two main devices studied are:
Organ Care System (OCS) Transmedics, a mobile machine for use at the donor site.
XPS XVIVO, a static machine used for organs transported with cold preservation. The study's primary objective is to assess the acceptance rate of organs treated with these devices, while secondary objectives include comparing the duration of mechanical ventilation, ECMO use, and 90-day survival rates in transplanted patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age greater than 18 years
- •informed consent
- •donor with at least one of the following: age greater than 55 years P/F on evaluation less than 350 mmHg smoker (more than 20 p/y) lung atelectasis on chest ct class II and III DCD according to Maastricht classification
排除标准
- •lung Haematoma or signsd of lung contusion
- •signs of infecton of the graft
研究组 & 干预措施
X vivo
干预措施: ex vivo lung perfusion for eventual lung transplant (Device)
OCS
干预措施: Organ Care system (Device)
结局指标
主要结局
Acceptance rate to transplant
时间窗: after the transplant
次要结局
- days on mechanical ventilation(from transplant moment since the day weaning from mechanical ventilation)
- duration on postoperative ECMO (ExtraCorporeal Membrane Oxygenation)(from transplant date since the day weaning from ECMO (ExtraCorporeal Membrane Oxygenation))
- mortality(within 90 days)
研究者
Filippo Antonacci
MD
IRCCS Azienda Ospedaliero-Universitaria di Bologna