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临床试验/EUCTR2020-001823-15-FR
EUCTR2020-001823-15-FR进行中(未招募)1 期

Evaluation of the concentration-effect relationship of enoxaparin for thromboembolic prevention in COVID-19 resuscitation patients. COV-ENOX study - COV-ENOX

CHU de Saint Etienne0 个研究点目标入组 200 人开始时间: 2020年4月15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)
发起方
入组人数
200

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 patients at least 18 years of age
  • - Patients hospitalized in the intensive care unit infected with SARS-CoV-
  • 2, for whom a diagnosis of respiratory SARS-CoV-2 infection was made
  • by nasopharyngeal swab or deep respiratory sampling (patients on HDON or artificial ventilation)
  • - Patient receiving enoxaparin therapy as part of care or as part of a clinical trial for the prevention or treatment of thromboembolic venous disease.
  • - Patient affiliated or entitled to a social security scheme
  • 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 100
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 100

排除标准

  • - Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWHs)
  • - History of immune-mediated heparin-induced thrombocytopenia (HIT) in the last 100 days or in the presence of circulating antibodies
  • - Active clinically significant bleeding or a condition associated with a high risk of bleeding, such as a recent hemorrhagic stroke, gastrointestinal ulcer, the presence of a malignant tumour at high risk of bleeding, recent brain, spinal or ophthalmologic surgery, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysm or major intrarachid or intracerebral vascular abnormalities.
  • - Spinal, epidural or locoregional anaesthesia or anaesthesia when enoxaparin sodium is used for curative treatment within the previous 24 hours

研究者

发起方
CHU de Saint Etienne

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