NCT03639025进行中(未招募)不适用
The Organ Care System (OCS™) Lung Thoracic Organ Perfusion (TOP) Registry for Donor Lungs for Transplantation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- TransMedics
- 入组人数
- 458
- 试验地点
- 18
- 主要终点
- 12-month patient and graft survival post double-lung transplant
研究概览
简要总结
Single-arm, prospective, multi-center, post-approval U.S. registry
详细描述
This is an all-comers registry that will enroll:
- Patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and
- Patients who receive a single lung transplant from OCS™ preserved lung pairs from either standard criteria donors or donors initially deemed unacceptable; and
- All donor lungs that were perfused on OCS Lung System.
Enrolled patients will fall into one of the following three possible analysis categories:
- TOP SCDL PAS Primary Analysis Population: will be comprised of recipients transplanted with SCDL primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
- TOP DLIDU Primary Analysis Population: Will be comprised of recipients transplanted with DLIDU primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
- All Other Enrolled Patients: will be comprised of all OCS Lung transplanted patients in the TOP Registry that do not meet any of the above analysis populations.
Patient enrollment in the TOP Registry will continue until 266 eligible DLIDU Primary Analysis Population recipients have been enrolled.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
12-month patient and graft survival post double-lung transplant
时间窗: 12 months
Primary Effectiveness Endpoint
次要结局
- Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 at 72 hours post-transplantation(72 hours)
- Standard Criteria Donor Lungs - Total ischemic time for OCS™-preserved lungs(2 hours)
- Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 within the initial 72 hours post-transplantation(Within 72 hours post-transplantation)
- Standard Criteria Lungs - Incidence of Primary Graft Dysfunction (PGD) grade 3 within the initial 72 hours post-transplantation (T0, T24, T48, and T72 hours)(0, 24, 48 and 72 hours)
- Donor Lungs Initially Deemed Unacceptable - Donor Lung Utilization Rate(1 hour)
研究者
研究点 (18)
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