International Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Lung For Recruiting, Preserving and Assessing Expanded Criteria Donor Lungs for Transplantation (EXPAND Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- TransMedics
- 入组人数
- 79
- 试验地点
- 22
- 主要终点
- Number of Participants With Composite Endpoint of Patient Survival at Day-30 Post Transplant and Absence of Primary Graft Dysfunction (PGD) Grade 3 During the First 72 Hours Post Lung Transplant
研究概览
简要总结
To evaluate the safety and effectiveness of the OCS™ Lung to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.
详细描述
The OCS™ Lung is to be used to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria from one or more of the following characteristics:
- Donor PaO2/FiO2 ≤ 300 mmHg; or
- Expected ischemic time > 6 hours; or
- Donor after Cardiac Death (DCD donor); or
- Donor age ≥55 years old
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one of the following:
- •Donor PaO2/FiO2 ≤ 300 mmHg; or
- •Expected ischemic time > 6 hours; or
- •Donor after Cardiac Death (DCD donor); or
- •Donor age ≥55 years old
排除标准
- •• Presence of moderate to severe traumatic lung injury with air and/or blood leak
- •Presence of confirmed active pneumonia or persistent purulent secretions on repeated bronchoscopy evaluation or ET suction
- •Previous history of pulmonary disease
- •Multiple transfusions of >10 pRBCs units
- •ABO incompatibility
- •Tobacco history of >20 pack years
结局指标
主要结局
Number of Participants With Composite Endpoint of Patient Survival at Day-30 Post Transplant and Absence of Primary Graft Dysfunction (PGD) Grade 3 During the First 72 Hours Post Lung Transplant
时间窗: 30 days post lung transplantation
Primary graft dysfunction is graded on a scale of 0 to 3 according to the 2005 ISHLT PGD grading consensus. Grade 0 is considered the least severe and grade 3 is considered a more severe outcome.
次要结局
- Number of Participants With ISHLT Primary Graft Dysfunction (PGD) Grade 2 or 3 at T72 Hours Post Lung Transplantation(72 hours post lung transplantation)
- Number of Participants With Primary Graft Dysfunction Grade 3 at T72 Hours(72 hours post lung transplantation)