Prevalence and Severity of Venous Thromboembolism in a General Population During the COVID-19 Pandemic

November 17, 2021 updated by: Daniel Wilhelms, University Hospital, Linkoeping
The purpose of this study is to investigate the prevalence of venous thromboembolism in a regional health care system (Region Östergötland, Sweden) before and during the SARS-COV-2 pandemic. In a retrospective observational study, we will review patient data, diagnostic data and treatment data over a three-month period since the onset of the SARS-COV-2 pandemic. This data will be compared with data from the corresponding time frame during the years 2015 to 2019.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the current SARS-COV-2 pandemic there is a concern about an increased risk of venous thromboembolism (VTE) concurrent with the infection, including both pulmonary embolism (PE) and deep venous thrombosis (DVT) (Klok et al. 2020; Cui et al. 2020; Helms et al. 2020; Leonard-Lorant et al. 2020; Poissy et al. 2020). International guidelines now recommend prophylactic anticoagulation for all hospitalized patients with a SARS-COV-2 infection in the absence of any contraindication (Thachil et al. 2020). The majority of the studies on VTE in SARS-COV-2 infections have been carried out in the ICU and show prevalence of VTE of between 20 and 30%.(Klok et al. 2020; Cui et al. 2020; Helms et al. 2020). This is a clear increase compared to the less than 10 % prevalence seen in other ICU patients (Muscedere, Heyland, and Cook 2007; Deborah Cook et al. 2005; D. Cook et al. 2000). However, a single center study on consecutive ICU patients with severe sepsis showed a prevalence of VTE of 37% (Kaplan et al. 2015) and another recent publication of patients with severe influenza A/H1N1 infection had a prevalence of VTE of 44% (Obi et al. 2019).

This raises the question whether the increase in VTE seen in recent publications of SARS-COV-2 infections is the result of the specific pathophysiology of the virus itself or the subsequent sepsis with multiorgan failure seen in most complicated and severe cases. The former would have large implications for patients treated outside the ICU and possibly outside hospitals (Thachil et al. 2020).

The aim of this study will be to investigate the prevalence of VTE in a regional healthcare system prior to, and during the SARS-COV-2 pandemic and the differences between ICU, hospitalized and outpatient cohorts.

Study Type

Observational

Enrollment (Actual)

7795

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

  • Sweden
    • Östergötland
      • Linköping, Östergötland, Sweden, 58185
        • University Hospital Linköping

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

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

For enrolment, we will consider all patients who have done a diagnostic examination for suspected VTE (pulmonary embolism och deep venous thrombosis) within the health care system of Region Östergötland during March, April and May 2015 through 2020. We will also include all patients with a new diagnosis of pulmonary embolism or deep venous thrombosis during the same time periods.

Region Östergötland/Östergötland County has a population of 465,495 (December 31, 2019).

Description

Inclusion Criteria:

  • Any patient that has done a Computer Tomography Angiography of the lungs between 1:st of March and 31:st of May each year from 2015 to 2020
  • Any patient that has done a Ultrasound of the legs between 1:st of March and 31:st of May each year from 2015 to 2020
  • Any patient with a new diagnosis of pulmonary embolism or deep venous thrombosis between 1:st of March and 31:st of May each year from 2015 to 2020

Exclusion Criteria:

  • Incomplete diagnostic examination
  • Follow-up examination of know acute VTE
  • Primary investigation done outside the healthcare system
  • Patient <18 years of age

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: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SARS-CoV-2 pos
Patients who have been tested positive for SARS-CoV-2 virus by either nasopharyngeal swab PCR or antibody testing.
Diagnostic test: Diagnostic examination for venous thromboembolism
Patients who have done a diagnostic examination for suspected VTE (pulmonary embolism och deep venous thrombosis) within the health care system of Region Östergötland. Patients without matching diagnostic examination but with a new diagnosis of pulmonary embolism or deep venous thrombosis during the same time periods will also be taking into account.
Other Names:
  • CT Pulmonary Angiogram (CTPA)
  • Ultrasound for deep venous thrombosis (DVT)
SARS-CoV-2 neg
Patients without symptoms for SARS-CoV-2 infection who haven't been tested for the virus or patients with symptoms who have been tested negative for SARS-CoV-2 virus by either nasopharyngeal swab PCR or antibody testing.
Diagnostic test: Diagnostic examination for venous thromboembolism
Patients who have done a diagnostic examination for suspected VTE (pulmonary embolism och deep venous thrombosis) within the health care system of Region Östergötland. Patients without matching diagnostic examination but with a new diagnosis of pulmonary embolism or deep venous thrombosis during the same time periods will also be taking into account.
Other Names:
  • CT Pulmonary Angiogram (CTPA)
  • Ultrasound for deep venous thrombosis (DVT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Is there an increased prevalence of venous thromboembolism in a regional healthcare system in Sweden during the SARS-CoV-2 pandemic?
Time Frame: March to May in 2020
March to May in 2020
Is a SARS-CoV-2-infection an isolated risk factor for thromboembolism?
Time Frame: March to May in 2020
March to May in 2020

Secondary Outcome Measures

Outcome Measure
Time Frame
Are there geographic differences in the prevalence of venous thromboembolism within the healthcare system?
Time Frame: March to May in 2020
March to May in 2020
Is venous thromboembolism associated with increased mortality adjusted for relevant comorbidities?
Time Frame: March to May in 2020
March to May in 2020
How long is the time between symptom onset of the SARS-CoV-2-infection and any subsequent venous thromboembolism?
Time Frame: March to May in 2020
March to May in 2020
Is treatment with prophylactic antithrombotic or anticoagulant treatment associated with increased survival?
Time Frame: March to May in 2020
March to May in 2020

Collaborators and Investigators

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

Sponsor

University Hospital, Linkoeping

Investigators

  • Principal Investigator: Matthias Jörg, MD, Emergency Department, University Hospital Linköping, Sweden
  • Principal Investigator: Jens Wretborn, MD, Emergency Department, University Hospital Linköping, Sweden
  • Principal Investigator: Patrik Benjaminsson Nyberg, PhD, Emergency Department, University Hospital Linköping, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

June 8, 2020

Primary Completion (Actual)

July 30, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

May 22, 2020

First Submitted That Met QC Criteria

May 22, 2020

First Posted (Actual)

May 26, 2020

Study Record Updates

Last Update Posted (Actual)

November 18, 2021

Last Update Submitted That Met QC Criteria

November 17, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SE2020-02701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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