Evaluation of a Marine OXYgen Carrier (HEMO2Life®) for hypOthermic Kidney Graft Preservation Before Transplantation (OXYOP): 4 Years Follow-up
试验速览
- 阶段
- 不适用
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- eGFR
研究概览
简要总结
4 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). We also analyzed some efficacy secondary end points using a paired analysis (local kidney receiving HEMO2life® versus contralateral kidney transplanted elsewhere in France). Oxyop4 aims to analyse 4 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
排除标准
- •patients refusing to participate
结局指标
主要结局
eGFR
时间窗: 4 years
estimated GFR (CKDEPI)
次要结局
- rejection rate(4 years)
- infection rate(4 years)
- hospitalization(4 years)
- patient survival(4 years)
- graft survival(4 years)
