Evaluation at 5 and 10 Years of Renal Transplant Patients Who Received a Graft Preserved in a Solution HEMO2life®
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- eGFR
研究概览
简要总结
5 and 10 years follow-up of the oxyop study.
详细描述
Oxyop (NCT02652520 PHRC) was a safety study evaluating the use of an oxygen carrier HEMO2life® as an additive in organ preservation solution in 60 transplanted kidneys. This was a national multicenter (6 centers) open-labeled safety study on HEMO2life® that included 58 recipients. The first patient was included on March 24th, 2016 and the study was completed on February 23th, 2018 (1 year of recruitment and 1 year of follow-up). Some efficacy secondary end points using a paired analysis was also analyzed (local kidney receiving HEMO2life® versus contralateral kidney transplanted elsewhere in France). Oxyop 5 and 10 years aims to analyse 5 and 10 years results.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •informed patients participating to the oxyop study
- •Patient having completed the OXYOP M12 follow-up visit
- •Patient agreeing to participate in the observational study
排除标准
- •Opposition to the use his medical data
- •patient deceased or with graft lost before M48
结局指标
主要结局
eGFR
时间窗: 10 years
estimated GFR (CKDEPI)
次要结局
- infection rate(5 and 10 years)
- rejection rate(5 and 10 years)
- graft survival(5 and 10 years)
- hospitalization(5 and 10 years)
- patient survival(5 and 10 years)