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

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ClinicalTrials.gov Identifier: NCT04374617
Recruitment Status : Completed
First Posted : May 5, 2020
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

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.

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

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.

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Study Type : Observational
Actual Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
Venous thromboembolism
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
Other Names:
  • Compression ultrasound (CUS)
  • Ct-Angiography




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Deaths [ Time Frame: 7 days ]
    Deaths from all causes during the follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with severe COVID-19 pneumonia admitted to the intensive care unit.
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

Information from the National Library of Medicine

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


Locations
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Spain
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
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
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Principal Investigator: Sergi Bellmunt, MD,PhD Hospital Vall d'Hebron
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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT04374617    
Other Study ID Numbers: PR(AG)213/2020
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We have planned to write a paper

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Pulmonary Embolism
Thrombosis
Thromboembolism
Embolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Critical Illness
Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections