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

Completed

• Conditions: SARS Virus

• Registration Number: NCT04567927
• Lead Sponsor: Chiesa Alessandro Felice

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.

Study Timeline

• Study Start: 2020-03-03
• Primary Completion: 2020-05-28
• Study Completion: 2020-05-28
• Status Verified: 2020-09
• Study First Submitted: 2020-09-18
• Study First Submitted QC: 2020-09-25
• Last Update Submitted: 2020-09-25
• Study First Posted: 2020-09-29
• Last Update Posted: 2020-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Period prevalence of deep vein thrombosis (DVT)	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

Trial Locations

Locations (1)

Ospedale Regionale di Bellinzona e Valli; 🇨🇭 Bellinzona, Ticino, Switzerland