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

COVID-19 Disease Clinical Trial

— VTE-COVID  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04359212
• Other study ID #: VTE-COVID
• Status: Completed
• Start date: May 1, 2020
• Est. completion date: July 31, 2020

Study information

• Verified date: April 2020
• Source: Quovadis Associazione
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• COVID-19 Disease
• Thromboembolism
• Thromboembolism, Venous
• Venous Thromboembolism

Intervention

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

Locations

Country	Name	City	State
Italy	Giuseppe Camporese	Padova

Sponsors (2)

Lead Sponsor	Collaborator
Quovadis Associazione	Azienda Ospedaliera di Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism	the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism	28 days
Secondary	the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism plus the asymptomatic incidentally detected pulmonary embolism	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