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临床试验/NCT04557631
NCT04557631撤回不适用

Evaluation of the Threshold for the Interpretation of the Results of a Method for the Blood Determination of Phosphatidyléthanol

University Hospital, Lille0 个研究点目标入组 30 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
30
主要终点
Frequency of patients with a Peth concentration greater than 200 µg/L

研究概览

简要总结

For an analytical validation of the method for the determination of blood hosphatidylethathanol, it is necessary to:

  • to compare the results of chronic and excessive ethanol patients with the cut-off proposed in the literature.
  • Also assess the stability of phosphatidylethanol in total blood collected, and in blotted dried blood stains (DBS), depending on temperature (ambient temperature and +4°C)

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Person with alcohol consumption ≥ 40g/day (women) and ≥ 60g/day (men) according to WHO criteria
  • Person hospitalized for a hospital withdrawal in the addiction service of Lille's hospital, without other distinctions.

排除标准

  • Patient opposing the use of their personal data in the study
  • Patient subject to protective measures (guardianship or curatorship)
  • Person deprived of liberty

结局指标

主要结局

Frequency of patients with a Peth concentration greater than 200 µg/L

时间窗: at the end of study (at 6 months)

次要结局

  • the concentration of Peth in blood in DBS(between T0 and 4 weeks and the end of study (at 6 months))
  • the concentration of Peth in blood in ambiant temperature(between T0 and 96h and the end of study (at 6 months))
  • the concentration of Peth in blood at 4°C(between T0 and 96h and the end of study (at 6 months))

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

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