An All Comers Registry For Normothermic Ex Vivo Lung Perfusion (EVLP) as Assessment of Donor Lungs for Transplant
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 315
- 试验地点
- 2
- 主要终点
- Survival at 1 year post-transplant
研究概览
简要总结
The XVIVO Registry is to collect standard of care clinical data from "all-comers" who are transplanted with an EVLP lung treated with the XVIVO Perfusion System™ in order to assess the long-term performance of the device, and monitor device-related serious adverse events. In addition, 4 and 5-year UNOS registry data of the 126 subjects who received an EVLP transplant under the NOVEL and NOVEL Extension studies are provided as part of the long-term safety and quality of life data. In addition, 4 and 5-year UNOS registry data of the 126 subjects who received an EVLP transplant under the NOVEL and NOVEL Extension studies are provided as part of the long-term safety and quality of life data.
详细描述
The XVIVO registry is an ongoing, observational, multicenter, retrospective review of patients exposed to XPS™ EVLP-treated lungs. The Registry study is aligned and managed by the UNOS and OPTN data collection process. This registry uses quarterly STAR file data requests for the OPTN data managed by UNOS.
The EVLP procedure and transplantation will be performed per XPS™ Instructions for Use and the treating physician's discretion. Post-transplant clinical care will follow the institution's standard-of-care policies.
OPTN updated the data collected since the submission of the protocol therefore the data collection has changed. The following data has updated collection:
- Collects if hospitalized since last follow-up (yes, no), not the number of hospitalizations
- Collects acute rejection episodes (yes treated, yes not treated, no), not the number of episodes
- Collects Karnofsky Score as replacement for Physical and functional capacity
- Employment limitations has been updated to working for income (yes or no)
- No longer collects BOS, XVIVO to request BOS evaluations on subjects with visits prior to June 30, 2020 and any other omissions of end points not available in the data requested via STAR request.
- Collects FEV1 (L) effective June 30, 2020 to calculate CLAD and diagnosis of CLAD, if applicable.
- No longer provides Other, Specify text in STAR request.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •This is an "All Comers Registry" hence will include all patients receiving EVLP lungs.
排除标准
- 未提供
结局指标
主要结局
Survival at 1 year post-transplant
时间窗: 12 months
Primary effectiveness endpoint
Primary Graft Dysfunction (PGD)
时间窗: 72 hours
Rate of Grade 3 Primary Graft Dysfunction (PGD) at 72 hours
次要结局
- Post-transplant survival(2 years, 3 years, 4 years and 5 years post-transplant)
- Karnofsky Performance Status Scale (KPS)/Karnofsky score(1 year, 2 years, 3 years, 4 years and 5 years post-transplant)
- Safety Endpoint(30 days post-transplant)
- Hospitalizations(1 year, 2 years, 3 years, 4 years and 5 years post-transplant)
- Pulmonary Function Test (FEV1)(1 year, 2 years, 3 years, 4 years and 5 years post-transplant)
- Incidence of Bronchiolitis Obliterans Syndrome (BOS) or Chronic Lung Allograft Dysfunction (CLAD)(1 year, 2 years, 3 years, 4 years and 5 years post-transplant)
- Acute Rejection Episodes(1 year, 1-2 years, 2-3 years, 3-4 years, and 4-5 years post-transplant)