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

• Sponsor: Chiesa Alessandro Felice (Other)
• Overall Status: Completed
• CT.gov ID: NCT04567927
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Actual Duration (Months): 2.8
• Patients Per Site Per Month: 28.3

Study Details

Study Description

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	Phase
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

• 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: Mar 3, 2020
• Actual Primary Completion Date: May 28, 2020
• Actual Study Completion Date: May 28, 2020

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients admitted to the Intensive Care Unit

• laboratory confirmed SARS-CoV-2 infection

• invasive respiratory support

Exclusion Criteria:

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale Regionale di Bellinzona e Valli	Bellinzona	Ticino	Switzerland	6500

Sponsors and Collaborators

• Chiesa Alessandro Felice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chiesa Alessandro Felice, Principal Investigator, Ente Ospedaliero Cantonale, Bellinzona
• ClinicalTrials.gov Identifier: NCT04567927
• Other Study ID Numbers: 2020-01266
• First Posted: Sep 29, 2020
• Last Update Posted: Sep 29, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Thromboembolism

Study Results

No Results Posted as of Sep 29, 2020