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

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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04359212
Acronym
VTE-COVID
Enrollment
90
Registered
2020-04-24
Start date
2020-05-01
Completion date
2020-07-31
Last updated
2020-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Disease, Thromboembolism, Venous

Keywords

COVID-19 pandemic, Thromboembolism, Venous, Deep Venous Thrombosis, Pulmonary Thrombosis

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.

Interventions

DRUGthromboprophylaxis with low-molecular-weight heparin or fondaparinux

thromboprophylaxis with low-molecular-weight heparin or fondaparinux

Sponsors

Azienda Ospedaliera di Padova
CollaboratorOTHER
Quovadis Associazione
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism28 daysthe cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism

Secondary

MeasureTime frameDescription
the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism plus the asymptomatic incidentally detected pulmonary embolism28 daysthe cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism plus the asymptomatic incidentally detected pulmonary embolism

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026