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Clinical Trials/NCT04567927
NCT04567927
Completed
Not Applicable

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

Chiesa Alessandro Felice1 site in 1 country80 target enrollmentMarch 3, 2020
ConditionsSARS Virus

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
SARS Virus
Sponsor
Chiesa Alessandro Felice
Enrollment
80
Locations
1
Primary Endpoint
Period prevalence of deep vein thrombosis (DVT)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 3, 2020
End Date
May 28, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chiesa Alessandro Felice
Responsible Party
Sponsor Investigator
Principal Investigator

Chiesa Alessandro Felice

Principal Investigator

Ente Ospedaliero Cantonale, Bellinzona

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Study Sites (1)

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