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OpenTrials
Completed

NCT Number: NCT04359212

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

thromboprophylaxis with low-molecular-weight heparin or fondaparinux

Drug

thromboprophylaxis with low-molecular-weight heparin or fondaparinux

Other names: thromboprophylaxis

Primary outcomes

  1. 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

  1. the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism plus the asymptomatic incidentally detected pulmonary embolism

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Quovadis Associazione

Other

Collaborators

  • Azienda Ospedaliera di Padova

Registry information

Official study 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)

Acronym: VTE-COVID

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 24, 2020
Registry last updated
Sep 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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