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

Completed

• Conditions: Venous Thromboembolism; Critical Illness; Sars-CoV2; Venous Thromboses, Deep; COVID-19; Venous Thromboses; Venous Thrombosis Pulmonary; Pulmonary Embolism; Pulmonary Embolism and Thrombosis; SARS-CoV Infection
• Interventions: Diagnostic Test: Duplex ultrasound and Computed Tomography Angiography

• Registration Number: NCT04374617
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-04-01
• Primary Completion: 2020-04-25
• Status Verified: 2020-05
• Study Completion: 2020-05-01
• Study First Submitted: 2020-05-02
• Study First Submitted QC: 2020-05-02
• Last Update Submitted: 2020-05-04
• Study First Posted: 2020-05-05
• Last Update Posted: 2020-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Venous thromboembolism	Duplex ultrasound and Computed Tomography Angiography	Patients at risk of venous thromboembolism (deep venous thrombosis and/or pulmonary embolism)

Primary Outcome Measures

Name	Time	Method
Venous thromboembolisms	7 days	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"

Secondary Outcome Measures

Name	Time	Method
Deaths	7 days	Deaths from all causes during the follow-up

Trial Locations

Locations (3)

Vall d´Hebron Research Institute VHIR; 🇪🇸 Barcelona, Catalunya, Spain

Hospital Germans Trias i Pujol. Universitat Autònoma de Barcelona; 🇪🇸 Badalona, Spain

Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona; 🇪🇸 Barcelona, Spain