Increased Risk of VTE and Higher Hypercoagulability in Patients Recovered in ICU and in Medical Ward for COVID-19 (VTE-COVID)

Quovadis Associazione

Status: Completed

Conditions: Thromboembolism, Venous; COVID-19 Disease

Treatments: Drug: thromboprophylaxis with low-molecular-weight heparin or fondaparinux

Study type: Observational

Funder types: Other

Identifiers

NCT04359212

VTE-COVID

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

90 participants in 2 patient groups

Medical

Description:

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

Treatment:

Drug: thromboprophylaxis with low-molecular-weight heparin or fondaparinux

Intensive

Description:

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

Treatment:

Drug: thromboprophylaxis with low-molecular-weight heparin or fondaparinux