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

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ClinicalTrials.gov Identifier: NCT04400877
Recruitment Status : Recruiting
First Posted : May 26, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Daniel Wilhelms, 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.

Condition or disease Intervention/treatment
COVID-19 Venous Thromboembolism Pulmonary Embolism Deep Vein Thrombosis SARS-CoV 2 Diagnostic Test: Diagnostic examination for venous thromboembolism

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.

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Study Type : Observational
Estimated Enrollment : 12000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prevalence and Severity of Venous Thromboembolism in a General Population During the COVID-19 Pandemic
Estimated Study Start Date : June 8, 2020
Estimated Primary Completion Date : June 19, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

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)




Primary Outcome Measures :
  1. 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 ]
  2. Is a SARS-CoV-2-infection an isolated risk factor for thromboembolism? [ Time Frame: March to May in 2020 ]

Secondary Outcome Measures :
  1. Are there geographic differences in the prevalence of venous thromboembolism within the healthcare system? [ Time Frame: March to May in 2020 ]
  2. Is venous thromboembolism associated with increased mortality adjusted for relevant comorbidities? [ Time Frame: March to May in 2020 ]
  3. 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 ]
  4. Is treatment with prophylactic antithrombotic or anticoagulant treatment associated with increased survival? [ Time Frame: March to May in 2020 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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).

Criteria

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

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): NCT04400877


Contacts
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Contact: Daniel Wilhelms, PhD +461030000 daniel.wilhelms@liu.se
Contact: Joakim Henricson, PhD +461030000 joakim.henricson@regionostergotland.se

Locations
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Sweden
University Hospital Linköping Recruiting
Linköping, Östergötland, Sweden, 58185
Contact: Daniel Wilhelms, PhD    +461030000    daniel.wilhelms@liu.se   
Contact: Joakim Henricson, PhD    +461030000    joakim.henricson@regionostergotland.se   
Sponsors and Collaborators
University Hospital, Linkoeping
Investigators
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Principal Investigator: Jens Wretborn, MD Emergency Department, University Hospital Linköping, Sweden
Principal Investigator: Patrik Benjaminsson Nyberg, PhD Emergency Department, University Hospital Linköping, Sweden
Principal Investigator: Matthias Jörg, MD Emergency Department, University Hospital Linköping, Sweden
Additional Information:
Publications:

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Responsible Party: Daniel Wilhelms, MD, Emergency department head of research, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT04400877    
Other Study ID Numbers: SE2020-02701
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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Pulmonary Embolism
Thrombosis
Thromboembolism
Embolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases