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Clinical Trials/NCT04374617
NCT04374617
Completed
Not Applicable

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

Hospital Universitari Vall d'Hebron Research Institute3 sites in 1 country230 target enrollmentApril 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Enrollment
230
Locations
3
Primary Endpoint
Venous thromboembolisms
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
May 1, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Venous thromboembolisms

Time Frame: 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 Outcomes

  • Deaths(7 days)

Study Sites (3)

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