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)
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
- 否
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)
