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Completed

NCT Number: NCT04567927

Prevalence and Risk Factors for Venous Thromboembolic Events in Critically Ill Patients With COVID-19

The purpose of the study is to assess the frequency of the occurrence of a venous thrombosis in patients with the new Coronavirus disease, who are admitted to the Intensive Care Unit for impending respiratory failure requiring intubation and mechanical ventilation. Furthermore, the investigators aim at identifying potential risk factors for thrombosis and death.

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Key information

Conditions

SARS Virus Coronaviridae Infections Coronavirus Infections Infections Nidovirales Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Regionale di Bellinzona e Valli

Bellinzona, Canton Ticino, 6500, Switzerland

About this study

Symptomatic infection with the severe acute respiratory syndrome coronavirus 2 ranges from mild to critical spectrum. About 80% of laboratory confirmed infections presented with mild symptoms, usually not requiring hospitalization. Critical disease requiring respiratory and/or circulatory support was reported in 5% of the subjects. Acute respiratory distress syndrome represents the most common complication in patients with severe disease. Several cases of venous thromboembolism in patients with laboratory confirmed infection have been reported, but it is unclear if this occurrence is higher in this specific patients' population. The purpose of the present study is to assess the prevalence of deep venous thrombosis in patients infected with SARS-CoV-2 admitted to the Intensive care Unit requiring invasive mechanical ventilation using vein ultrasonography.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients admitted to the Intensive Care Unit
  • laboratory confirmed SARS-CoV-2 infection
  • invasive respiratory support

Exclusion criteria

  • none

Treatment and study plan

Ultrasonography

Other

Venous compression ultrasonography using real-time B-mode and colour doppler in transverse and longitudinal views

Primary outcomes

  1. Period prevalence of deep vein thrombosis (DVT)

    Time frame: From date of inclusion in the study until the date of development of a DVT, date of death from any cause, or date of discharge from the ICU, whichever came first, assessed up to 3 months

    Percent (%) of patients with a DVT

Sponsors and collaborators

Lead sponsor

Chiesa Alessandro Felice

Other

Registry information

Official study title

Prevalence and Risk Factors for Venous Thromboembolic Events in Critically Ill Patients With SARS-CoV-2 Infection

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 29, 2020
Registry last updated
Sep 29, 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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