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临床试验/NCT04366752
NCT04366752已完成不适用

Thrombo Embolic Events in Critical Care Patients With Covid-19 Serious Acute Pneumopathy

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2020年4月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
1
主要终点
Variation of thrombin time (in secondes) in Covid-19 patients with pneumonia admitted in ICU.

研究概览

简要总结

The understanding of haemostasis and inflammation cross-talk has gained considerable knowledge during the past decade in the field of arterial and venous thrombosis. Complex and delicately balanced interaction between coagulation and inflammation involve all cellular and humoral components. Elements of the coagulation system such as activated thrombin, fibrinogen or factor Xa may increase inflammation by promoting the production of pro-inflammatory cytokines, chemokines, growth factors and adhesion molecules that lead to a procoagulant state amplifying the pathological process. Recent evidence supports inflammation as a common pathogenic contributor to both arterial and venous thrombosis, giving rise to the concept of inflammation-induced thrombosis.

Patients with infection of COVID-19 and severe pneumoniae seem to have higher risk of thromboembolism. Very few data are available regarding the biological disorders of coagulation in these patients. Th purpose of this project is to analyze hemostasis and coagulation of patients with infection of COVID-19 and severe pneumonia.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • patients hospitalized in medical ICU with pneumonia due to COVID-19 infection

排除标准

  • patients< 18 years

结局指标

主要结局

Variation of thrombin time (in secondes) in Covid-19 patients with pneumonia admitted in ICU.

时间窗: up to 6 weeks

The reference range for the thrombin time is usually less than 20 seconds (ie, 15-19 seconds)

Variation of factor V concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.

时间窗: up to 6 weeks

Variation of factor V concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.

Variation of factor II concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.

时间窗: up to 6 weeks

Variation of factor II concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.

Variation of concentration of fibrin and fibrinogen degradation products (≥ 10 µgm/mL) in Covid-19 patients with pneumonia admitted in ICU.

时间窗: up to 6 weeks

Variation of concentration of fibrin and fibrinogen degradation products (≥ 10 µgm/mL) in Covid-19 patients with pneumonia admitted in ICU.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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