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临床试验/NCT04359212
NCT04359212已完成不适用

Increased Risk of Venous Thromboembolism and Higher Hypercoagulable State in Patients Recovered in Intensive Care Unit and in Medical Ward for Coronavirus Disease 2019 (COVID-19)

Quovadis Associazione1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism

研究概览

简要总结

The aim of this study is to verify if patients admitted to hospital in a medical division and in the intensive care unit for a COVID-19 infection are at higher risk of developing a VTE complication and if they actually present an increased hypercoagulable state.

详细描述

Between December 2019 and January 2020, a new type of coronavirus, named as "coronavirus disease 2019 - COVID-19" by the World Health Organization, has widely spread throughout the world, becoming a global health threat. The new COVID-19 is similar to other two types of coronavirus that in the past two decades have emerged as cause of severe human disease: Severe Acute Respiratory Syndrome CoV (SARS-CoV) and Middle East Respiratory Syndrome CoV (MERS-CoV). Severe respiratory disease or respiratory failure are the principal symptoms of critical patients, needing a management in ICU with mechanical ventilation.18 Data coming from laboratory results show a leucopenia mainly represented by a lymphopenia, that is a cardinal feature of COVID-19. Moreover, the concentration of several serum pro-thrombotic cytokines, such as interleukins (mainly IL-6, increased in 52% of patients), TNF-α, D-Dimer are reported to be significantly higher in COVID-19 patients, and significantly higher in ICU-patients than in non-ICU patients, suggesting an increased hypercoagulable state that, joined to the other main risk factors (immobilization, ICU admission, mechanical ventilation, infective disease), place these patients to a potential greater risk of developing VTE complications.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • aged >= 18 years
  • needing admission to a medical hospital division or to an ICU
  • with a confirmed infection for COVID-19

排除标准

  • aged < 18 years

研究组 & 干预措施

Medical

subject with a confirmed infection for COVID-19 and needing admission to a medical division for a non-severe clinical disease

干预措施: thromboprophylaxis with low-molecular-weight heparin or fondaparinux (Drug)

Intensive

subject with a confirmed infection for COVID-19 and needing admission to an Intensive Cure Unit for a severe to critical disease

干预措施: thromboprophylaxis with low-molecular-weight heparin or fondaparinux (Drug)

结局指标

主要结局

the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism

时间窗: 28 days

the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism

次要结局

  • the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism plus the asymptomatic incidentally detected pulmonary embolism(28 days)

研究者

发起方
Quovadis Associazione
申办方类型
Other
责任方
Sponsor

研究点 (1)

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