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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04374617
• Other study ID #: PR(AG)213/2020
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: May 1, 2020

Study information

• Verified date: May 2020
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: May 1, 2020
• Est. primary completion date: April 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19
• Critical Illness
• Embolism
• Embolism and Thrombosis
• Pulmonary Embolism
• Pulmonary Embolism and Thrombosis
• SARS-CoV Infection
• Sars-CoV2
• Severe Acute Respiratory Syndrome
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thromboses
• Venous Thromboses, Deep
• Venous Thrombosis
• Venous Thrombosis Pulmonary

Intervention

Diagnostic Test:
• Duplex ultrasound and Computed Tomography Angiography
All venous thromboembolisms suspected will diagnosed with ultrasound and CT-angiography

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol. Universitat Autònoma de Barcelona	Badalona
Spain	Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona	Barcelona
Spain	Vall d´Hebron Research Institute VHIR	Barcelona	Catalunya

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Deaths	Deaths from all causes during the follow-up	7 days