NCT07340710尚未招募不适用
Decreasing Edema With a Novel OCS Solution (DENOVO) Trial
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- TransMedics
- 入组人数
- 450
- 主要终点
- 30-day patient and graft survival with freedom from PGD3
研究概览
简要总结
This is a prospective, multicenter randomized trial of lung transplant recipients transplanted with either a DBD or DCD donor lungs. The DENOVO Trial will enroll a total of 300 patients in the OCS arm and 150 patients in the SCS arm. The primary endpoint will be patient & graft survival and freedom of Primary Graft Dysfunction (PGD) grade 3 within the initial 72 hours post-transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Donor Inclusion/
排除标准
- •Inclusion Criteria:
- •Donor lungs are deemed clinically acceptable for transplantation after physical examination of the donor lungs in the donor and/or on the back table in the donor operating room.
- •Eligible for randomization to OCS or SCS treatment arms.
- •Exclusion Criteria:
- •- Severe traumatic donor lung injury with air and/or blood leak (as seen on radiological studies, bronchial examinations or final visual physical assessment in donor's chest or back table).
- •Recipient Inclusion/Exclusion:
- •Inclusion Criteria:
- •Signed informed consent document and authorization to use and disclose protected health information
- •Double lung transplant candidate
- •Age ≥ 18 years old
- •- Participant in any other interventional clinical or investigational trials/programs that may confound the outcomes of this trial.
研究组 & 干预措施
Static Cold Storage
Active Comparator
干预措施: Static Cold Storage (Other)
OCS Lung
Experimental
干预措施: OCS Lung System (Device)
结局指标
主要结局
30-day patient and graft survival with freedom from PGD3
时间窗: 30-days post-transplant
The primary endpoint is 30-day patient and graft survival with freedom from PGD 3 within the initial 72-hours (T0-T72).
次要结局
未报告次要终点
研究者
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