COVID-19 Disease, Thromboembolism, Venous
Conditions
Keywords
COVID-19 pandemic, Thromboembolism, Venous, Deep Venous Thrombosis, Pulmonary Thrombosis
Brief summary
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.
Detailed description
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.
Interventions
thromboprophylaxis with low-molecular-weight heparin or fondaparinux
Sponsors
Study design
Eligibility
Inclusion criteria
* aged \>= 18 years * needing admission to a medical hospital division or to an ICU * with a confirmed infection for COVID-19
Exclusion criteria
* aged \< 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism | 28 days | the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism plus the asymptomatic incidentally detected pulmonary embolism |
Countries
Italy