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临床试验/NCT05050513
NCT05050513Unknown不适用

Evaluation of a Marine OXYgen Carrier (HEMO2Life®) for hypOthermic Kidney Graft Preservation Before Transplantation (OXYOP): 4 Years Follow-up

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2021年5月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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