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

Completed

• Conditions: COVID-19 Disease; Thromboembolism, Venous
• Interventions: Drug: thromboprophylaxis with low-molecular-weight heparin or fondaparinux

• Registration Number: NCT04359212
• Lead Sponsor: Quovadis Associazione

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.

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-04-21
• Study First Posted: 2020-04-24
• Study Start: 2020-05-01
• Primary Completion: 2020-06-30
• Study Completion: 2020-07-31
• Last Update Submitted: 2020-09-15
• Last Update Posted: 2020-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Medical	thromboprophylaxis with low-molecular-weight heparin or fondaparinux	subject with a confirmed infection for COVID-19 and needing admission to a medical division for a non-severe clinical disease
Intensive	thromboprophylaxis with low-molecular-weight heparin or fondaparinux	subject with a confirmed infection for COVID-19 and needing admission to an Intensive Cure Unit for a severe to critical disease

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Giuseppe Camporese; 🇮🇹 Padova, Italy