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

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ClinicalTrials.gov Identifier: NCT04567927
Recruitment Status : Completed
First Posted : September 29, 2020
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
Chiesa Alessandro Felice, Ente Ospedaliero Cantonale, Bellinzona

Study Description
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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.

Condition or disease Intervention/treatment
SARS Virus Other: Ultrasonography

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 Design
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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence and Risk Factors for Venous Thromboembolic Events in Critically Ill Patients With SARS-CoV-2 Infection
Actual Study Start Date : March 3, 2020
Actual Primary Completion Date : May 28, 2020
Actual Study Completion Date : May 28, 2020
Groups and Cohorts
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Intervention Details:
  • Other: Ultrasonography
    Venous compression ultrasonography using real-time B-mode and colour doppler in transverse and longitudinal views

Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All consecutive adult patients with laboratory confirmed SARS-CoV-2 infection admitted to the Intensive Care Unit requiring invasive respiratory support
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04567927


Locations
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Switzerland
Ospedale Regionale di Bellinzona e Valli
Bellinzona, Ticino, Switzerland, 6500
Sponsors and Collaborators
Chiesa Alessandro Felice
More Information
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Publications of Results:

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Responsible Party: Chiesa Alessandro Felice, Principal Investigator, Ente Ospedaliero Cantonale, Bellinzona
ClinicalTrials.gov Identifier: NCT04567927    
Other Study ID Numbers: 2020-01266
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases