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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04400877
Enrollment
7795
Registered
2020-05-26
Start date
2020-06-08
Completion date
2020-09-30
Last updated
2021-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Deep Vein Thrombosis, Pulmonary Embolism, SARS-CoV 2, Venous Thromboembolism

Brief summary

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.

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.

Interventions

DIAGNOSTIC_TESTDiagnostic 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.

Sponsors

University Hospital, Linkoeping
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026