An Observational Study of a Dedicated Preservation and Assessment Service to Optimize Organ Utilization for Hard-to-Place Kidneys
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 8
- 主要终点
- Transplant Allocation Success
研究概览
简要总结
This is a study to collect information to assess if transporting hard-to-place (HTP) donor kidneys to a central preservation and assessment facility with dedicated organ assessment capabilities increases allocation success to transplant hospitals.
详细描述
This is an Observational study of a centralized kidney assessment facility providing brief sub-normothermic machine perfusion (SNMP) to HTP donor kidneys to provide transplant centers additional information for accepting HTP kidneys.
This study is intended to collect data to evaluate the feasibility of a dedicated central service to determine if additional assessment data helps increase allocation to transplant centers. Transplantation will follow standard-of-care at each transplant center, including required post-transplant data collection, which must be reported to the OPTN registry by the center.
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
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be considered HTP, by receiving refusals from every transplant center within the 250 nm allocation radius or similar definition by the local OPO.
- •From a Male or female deceased donor, aged 16- 75 years old.
- •Kidney initially procured, preserved, and packaged with intent to transplant.
- •LAP provides informed consent for organ donation for transplant and research purposes.
- •The HTP donor kidney must be allocated to a participating transplant center by a participating OPO, and the transplant center makes the decision to send kidney to Sponsor's central preservation and assessment facility for SNMP assessment and preservation prior to determining suitability for allocation.
- •Donor Kidney
排除标准
- •From a Donor with pre-admission diagnosis of end stage renal failure.
- •Obvious surgical damage to artery(s), vein(s), or ureter(s) preventing machine perfusion.
- •From a donor with confirmed HIV (+), HBVSAg (+) and/or HCV NAT (+) serology results.
- •No LAP consent for both transplant and research purposes.
- •Cannot arrive to Sponsor's central preservation and assessment facility before reaching 24 hours of cold ischemic time (CIT).
结局指标
主要结局
Transplant Allocation Success
时间窗: 1 year
The primary objective for this study is a 50% success rate or higher for allocation of Hard-to-Place (HTP) kidneys to a participating transplant center after sNMP assessment at the Sponsor's central facility.
次要结局
- Long term data collection- eGFR(Annually, up to 3-years post-transplant)
- Graft Survival(1- and 3-months post-transplant)
- Long term data collection- Graft Survival(Annually, up to 3-years post-transplant)
- Long term data collection- Patient Survival(Annually, up to 3-years post-transplant)
- Long term data collection- Serum Creatinine(Annually, up to 3-years post-transplant)
- 7-Day Delayed Graft Function (DGF)(7 days post-transplant)
- Patient Survival(1- and 3-months post-transplant)
- Serum Creatinine (sCr)(1- and 3-months post-transplant)
- eGFR(1- and 3-months post-transplant)