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

NCT ID: NCT04374617

Last Updated: 2020-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2020-05-01

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.

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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.

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Venous thromboembolism

Patients at risk of venous thromboembolism (deep venous thrombosis and/or pulmonary embolism)

Duplex ultrasound and Computed Tomography Angiography

Intervention Type DIAGNOSTIC_TEST

All venous thromboembolisms suspected will diagnosed with ultrasound and CT-angiography

Interventions

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Duplex ultrasound and Computed Tomography Angiography

All venous thromboembolisms suspected will diagnosed with ultrasound and CT-angiography

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Compression ultrasound (CUS) Ct-Angiography

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sergi Bellmunt, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Vall d'Hebron

Locations

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Vall d´Hebron Research Institute VHIR

Barcelona, Catalonia, Spain

Site Status

Hospital Germans Trias i Pujol. Universitat Autònoma de Barcelona

Badalona, , Spain

Site Status

Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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PR(AG)213/2020

Identifier Type: -

Identifier Source: org_study_id

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