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)
Overview
- Phase
- Not Applicable
- Intervention
- thromboprophylaxis with low-molecular-weight heparin or fondaparinux
- Conditions
- COVID-19 Disease
- Sponsor
- Quovadis Associazione
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Medical
subject with a confirmed infection for COVID-19 and needing admission to a medical division for a non-severe clinical disease
Intervention: thromboprophylaxis with low-molecular-weight heparin or fondaparinux
Intensive
subject with a confirmed infection for COVID-19 and needing admission to an Intensive Cure Unit for a severe to critical disease
Intervention: thromboprophylaxis with low-molecular-weight heparin or fondaparinux
Outcomes
Primary Outcomes
the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism
Time Frame: 28 days
the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism
Secondary Outcomes
- 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)