Risk of Venous Thromboembolism in Critically Ill Patients With Severe COVID-19
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04374617|
Recruitment Status : Completed
First Posted : May 5, 2020
Last Update Posted : May 6, 2020
|Condition or disease||Intervention/treatment|
|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||Diagnostic Test: Duplex ultrasound and Computed Tomography Angiography|
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 Type :||Observational|
|Actual Enrollment :||230 participants|
|Official Title:||Risk of Venous Thromboembolism in Critically Ill Patients With Severe COVID-19|
|Actual Study Start Date :||April 1, 2020|
|Actual Primary Completion Date :||April 25, 2020|
|Actual Study Completion Date :||May 1, 2020|
Patients at risk of venous thromboembolism (deep venous thrombosis and/or pulmonary embolism)
Diagnostic Test: Duplex ultrasound and Computed Tomography Angiography
All venous thromboembolisms suspected will diagnosed with ultrasound and CT-angiography
- 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"
- Deaths [ Time Frame: 7 days ]Deaths from all causes during the follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04374617
|Vall d´Hebron Research Institute VHIR|
|Barcelona, Catalunya, Spain, 08035|
|Hospital Germans Trias i Pujol. Universitat Autònoma de Barcelona|
|Badalona, Spain, 08916|
|Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona|
|Barcelona, Spain, 08035|
|Principal Investigator:||Sergi Bellmunt, MD,PhD||Hospital Vall d'Hebron|