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临床试验/EUCTR2018-003232-80-FR
EUCTR2018-003232-80-FR进行中(未招募)1 期

RENACTIF: Reduction of the Thrombotic Phenotype in Renal Insufficiency With N-AcetylCysteine : A Randomized, Double-blind, Placebo-controlled, Cross-over Trial - RENACTIF

ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE0 个研究点目标入组 40 人开始时间: 2018年10月25日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Adult subjects of both sexes aged 18 years and over
  • Affiliated subjects or beneficiaries of a social security scheme
  • Hemodialysis patients regardless of the etiology of their renal insufficiency for more than three months on a cycle of three sessions per week
  • Hemodialysis patients at least four hours per dialysis session
  • Patients with a weight of more than 40kg
  • Subjects capable of giving informed consent, agreeing to participate in the study and having signed a consent
  • Patient able to understand a written questionnaire
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 30
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 10

排除标准

  • Pregnant or lactating women
  • Persons deprived of their liberty or hospitalized without consent
  • Majors under legal protection or unable to express their consent Possibility of recovery of renal function
  • Chronic progressive infection that may affect their thrombotic risk: progressive neoplasia, anticoagulant treatment prescribed for less than 1 month
  • Patients with a weight under 40 kg
  • Patient not able to express his consent
  • Patient taking AVK-type oral anticoagulants outside anticoagulation during the session.
  • Patient with a known allergy to the active molecule or an excipient

研究者

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