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

May 4, 2020 updated by: Hospital Universitari Vall d'Hebron Research Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badalona, Spain, 08916
        • Hospital Germans Trias i Pujol. Universitat Autònoma de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
        • Vall d´Hebron Research Institute VHIR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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"
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deaths
Time Frame: 7 days
Deaths from all causes during the follow-up
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Investigators

  • Principal Investigator: Sergi Bellmunt, MD,PhD, Hospital Vall d'Hebron

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

April 25, 2020

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

May 2, 2020

First Submitted That Met QC Criteria

May 2, 2020

First Posted (Actual)

May 5, 2020

Study Record Updates

Last Update Posted (Actual)

May 6, 2020

Last Update Submitted That Met QC Criteria

May 4, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(AG)213/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

We have planned to write a paper

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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