Risk of Venous Thromboembolism in Critically Ill Patients With Severe COVID-19

Study Overview
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Brief Summary
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Severe COVID-19 patients at a high risk of venous thromboembolism. We studied patients in 2 intensive care units of university hospitals in Barcelona and Badalona, Spain. We performed a cut-off screening of deep venous thrombosis (DVT) with bilateral duplex ultrasound to 230 patients.

Detailed Description
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SARS-CoV-2 infection has been associated with coagulation disorders and increased risk of venous thromboembolism (VTE). The aim of the study is to determine the cumulative incidence of VTE in critically ill patients with COVID-19 and its impact on prognosis. Methods Cohort study of critically ill patients due to COVID-19. A bilateral venous compression (CUS) ultrasound screening of the lower extremities was performed during a cut-off period in 2 intensive care units of university hospitals in Spain. Asymptomatic and symptomatic VTE were registered: pulmonary embolism (PE) (diagnosed by CT-angiography) and deep venous thrombosis (DVT). The characteristics of the patients, results of their blood tests and their evolution after 7 days of follow-up were recorded.

Official Title
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Risk of Venous Thromboembolism in Critically Ill Patients With Severe COVID-19

Conditions
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COVID-19, Critical Illness, Venous Thromboembolism, Venous Thromboses, Venous Thromboses, Deep, Venous Thrombosis Pulmonary, Pulmonary Embolism, Pulmonary Embolism and Thrombosis, Sars-CoV2, SARS-CoV Infection

Intervention / Treatment
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* Diagnostic Test: Duplex ultrasound and Computed Tomography Angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with severe COVID-19 pneumonia admitted to the intensive care unit Exclusion Criteria: Treatment with Extracorporeal membrane oxygenation (ECMO) Pregnant or postpartum women Under 18 years old

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Venous thromboembolism<br>Patients at risk of venous thromboembolism (deep venous thrombosis and/or pulmonary embolism) | Diagnostic Test: Duplex ultrasound and Computed Tomography Angiography<br>* All venous thromboembolisms suspected will diagnosed with ultrasound and CT-angiography<br>* Other names: Ct-Angiography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous thromboembolisms | Patients with symptomatic pulmonary embolism confirmed on the CT-angiography and those with a swollen limb and confirmed deep venous thrombosis on compression ultrasound were considered to have symptomatic venous thromboembolisms. The remaining patients with positive limb ultrasound or CT-angiography were considered to have asymptomatic venous thrombembolism | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deaths | Deaths from all causes during the follow-up | 7 days |