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

NCT04374617 | Completed

• 1 other identifier: PR(AG)213/2020
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Deaths

  7 days

Study Arms (1)

Venous thromboembolism

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

Diagnostic Test: Duplex ultrasound and Computed Tomography Angiography

Interventions

Duplex ultrasound and Computed Tomography Angiography DIAGNOSTIC_TEST

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

Also known as: Compression ultrasound (CUS), Ct-Angiography

Venous thromboembolism

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with severe COVID-19 pneumonia admitted to the intensive care unit.

You may qualify if:

• Patients with severe COVID-19 pneumonia admitted to the intensive care unit

You may not qualify if:

• Treatment with Extracorporeal membrane oxygenation (ECMO)
• Pregnant or postpartum women
• Under 18 years old

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (3)

Vall d´Hebron Research Institute VHIR

Barcelona, Catalonia, 08035, Spain

Location

Hospital Germans Trias i Pujol. Universitat Autònoma de Barcelona

Badalona, 08916, Spain

Location

Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

COVID-19; Critical Illness; Venous Thromboembolism; Venous Thrombosis; Pulmonary Embolism; Thrombosis; Severe Acute Respiratory Syndrome

Interventions

Ultrasonography, Doppler, Duplex; Computed Tomography Angiography

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Embolism

Intervention Hierarchy (Ancestors)

Ultrasonography, Doppler; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Image Interpretation, Computer-Assisted; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Sergi Bellmunt, MD,PhD

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2020
• First Posted: May 5, 2020
• Study Start: April 1, 2020
• Primary Completion: April 25, 2020
• Study Completion: May 1, 2020
• Last Updated: May 6, 2020

Record last verified: 2020-05

Locations

ES (3)