跳至主要内容
临床试验/NCT04377490
NCT04377490招募中不适用

Thrombo Embolic Events in Hospitalized 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 100 人开始时间: 2020年5月4日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Variation of thrombin time (in secondes) in Hospitalized Covid-19 patients

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 proinflammatory 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. The purpose of this project is to analyze hemostasis and coagulation of every hospitalized patient with infection of COVID-19.

Blood sample for coagulation and hemostasis analysis will be collected on every patient hospitalized in Amiens hospital for COVID-19 infection. Thrombin time, factors V and II, fibrin/fibrinogen degradation products, antithrombin will be assessed every week. Anticardiolipin, anti-beta2 glycoprotein I and anti-annexin A2 antibodies IgG and IgM at day of admission and at fourth week after admission will be assessed. SARS-CoV2 viral load and serodiagnosis will be performed at the same time. At the same time venous ultrasound to diagnose thrombosis will be performed.

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

  • all patients hospitalized in Amiens Hospital with 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 Hospitalized Covid-19 patients

时间窗: up to 6 weeks

Variation of thrombin time (in secondes) in Hospitalized Covid-19 patients. 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 Hospitalized Covid-19 patients.

时间窗: up to 6 weeks

Variation of factor V concentration (U/dL) in Hospitalized Covid-19 patients.

Variation of factor II concentration (U/dL) in Hospitalized Covid-19 patients

时间窗: up to 6 weeks

Variation of factor II concentration (U/dL) in Hospitalized Covid-19 patients

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

时间窗: up to 6 weeks

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

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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