Prevalence and Severity of Venous Thromboembolism in a General Population During the COVID-19 Pandemic
- Conditions
- COVID-19Venous ThromboembolismSARS-CoV 2Pulmonary EmbolismDeep Vein Thrombosis
- Interventions
- Diagnostic Test: Diagnostic examination for venous thromboembolism
- Registration Number
- NCT04400877
- Lead Sponsor
- University Hospital, Linkoeping
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7795
- 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
- Incomplete diagnostic examination
- Follow-up examination of know acute VTE
- Primary investigation done outside the healthcare system
- Patient <18 years of age
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SARS-CoV-2 pos Diagnostic examination for venous thromboembolism Patients who have been tested positive for SARS-CoV-2 virus by either nasopharyngeal swab PCR or antibody testing. SARS-CoV-2 neg Diagnostic examination for venous thromboembolism 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 Are there geographic differences in the prevalence of venous thromboembolism within the healthcare system? March to May in 2020 Is treatment with prophylactic antithrombotic or anticoagulant treatment associated with increased survival? March to May in 2020
Trial Locations
- Locations (1)
University Hospital Linköping
🇸🇪Linköping, Östergötland, Sweden