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
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