Prevalence and Severity of Venous Thromboembolism in a General Population During the COVID-19 Pandemic
NCT ID: NCT04400877
Last Updated: 2021-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
7795 participants
OBSERVATIONAL
2020-06-08
2020-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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SARS-CoV-2 pos
Patients who have been tested positive for SARS-CoV-2 virus by either nasopharyngeal swab PCR or antibody testing.
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.
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 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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Follow-up examination of know acute VTE
* Primary investigation done outside the healthcare system
* Patient \<18 years of age
18 Years
ALL
No
Sponsors
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University Hospital, Linkoeping
OTHER
Responsible Party
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Daniel Wilhelms
MD, Emergency department head of research
Principal Investigators
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Jens Wretborn, MD
Role: PRINCIPAL_INVESTIGATOR
Emergency Department, University Hospital Linköping, Sweden
Patrik Benjaminsson Nyberg, PhD
Role: PRINCIPAL_INVESTIGATOR
Emergency Department, University Hospital Linköping, Sweden
Matthias Jörg, MD
Role: PRINCIPAL_INVESTIGATOR
Emergency Department, University Hospital Linköping, Sweden
Locations
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University Hospital Linköping
Linköping, Östergötland County, Sweden
Countries
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References
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Cook D, Attia J, Weaver B, McDonald E, Meade M, Crowther M. Venous thromboembolic disease: an observational study in medical-surgical intensive care unit patients. J Crit Care. 2000 Dec;15(4):127-32. doi: 10.1053/jcrc.2000.19224.
Cook D, Crowther M, Meade M, Rabbat C, Griffith L, Schiff D, Geerts W, Guyatt G. Deep venous thrombosis in medical-surgical critically ill patients: prevalence, incidence, and risk factors. Crit Care Med. 2005 Jul;33(7):1565-71. doi: 10.1097/01.ccm.0000171207.95319.b2.
Cui S, Chen S, Li X, Liu S, Wang F. Prevalence of venous thromboembolism in patients with severe novel coronavirus pneumonia. J Thromb Haemost. 2020 Jun;18(6):1421-1424. doi: 10.1111/jth.14830. Epub 2020 May 6.
Helms J, Tacquard C, Severac F, Leonard-Lorant I, Ohana M, Delabranche X, Merdji H, Clere-Jehl R, Schenck M, Fagot Gandet F, Fafi-Kremer S, Castelain V, Schneider F, Grunebaum L, Angles-Cano E, Sattler L, Mertes PM, Meziani F; CRICS TRIGGERSEP Group (Clinical Research in Intensive Care and Sepsis Trial Group for Global Evaluation and Research in Sepsis). High risk of thrombosis in patients with severe SARS-CoV-2 infection: a multicenter prospective cohort study. Intensive Care Med. 2020 Jun;46(6):1089-1098. doi: 10.1007/s00134-020-06062-x. Epub 2020 May 4.
Kaplan D, Casper TC, Elliott CG, Men S, Pendleton RC, Kraiss LW, Weyrich AS, Grissom CK, Zimmerman GA, Rondina MT. VTE Incidence and Risk Factors in Patients With Severe Sepsis and Septic Shock. Chest. 2015 Nov;148(5):1224-1230. doi: 10.1378/chest.15-0287.
Klok FA, Kruip MJHA, van der Meer NJM, Arbous MS, Gommers DAMPJ, Kant KM, Kaptein FHJ, van Paassen J, Stals MAM, Huisman MV, Endeman H. Incidence of thrombotic complications in critically ill ICU patients with COVID-19. Thromb Res. 2020 Jul;191:145-147. doi: 10.1016/j.thromres.2020.04.013. Epub 2020 Apr 10.
Leonard-Lorant I, Delabranche X, Severac F, Helms J, Pauzet C, Collange O, Schneider F, Labani A, Bilbault P, Moliere S, Leyendecker P, Roy C, Ohana M. Acute Pulmonary Embolism in Patients with COVID-19 at CT Angiography and Relationship to d-Dimer Levels. Radiology. 2020 Sep;296(3):E189-E191. doi: 10.1148/radiol.2020201561. Epub 2020 Apr 23.
Muscedere JG, Heyland DK, Cook D. Venous thromboembolism in critical illness in a community intensive care unit. J Crit Care. 2007 Dec;22(4):285-9. doi: 10.1016/j.jcrc.2007.02.003. Epub 2007 Jul 5.
Poissy J, Goutay J, Caplan M, Parmentier E, Duburcq T, Lassalle F, Jeanpierre E, Rauch A, Labreuche J, Susen S; Lille ICU Haemostasis COVID-19 Group. Pulmonary Embolism in Patients With COVID-19: Awareness of an Increased Prevalence. Circulation. 2020 Jul 14;142(2):184-186. doi: 10.1161/CIRCULATIONAHA.120.047430. Epub 2020 Apr 24. No abstract available.
Thachil J, Tang N, Gando S, Falanga A, Cattaneo M, Levi M, Clark C, Iba T. ISTH interim guidance on recognition and management of coagulopathy in COVID-19. J Thromb Haemost. 2020 May;18(5):1023-1026. doi: 10.1111/jth.14810. Epub 2020 Apr 27. No abstract available.
Wretborn J, Jorg M, Benjaminsson Nyberg P, Wilhelms DB. Risk of venous thromboembolism in patients with COVID-19 during 2020; a retrospective cross-sectional study in a Swedish health care system. Sci Rep. 2023 Apr 4;13(1):5469. doi: 10.1038/s41598-023-32637-x.
Related Links
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Complete study protocol as used for approval at the Swedish Ethical Review Authority
Other Identifiers
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SE2020-02701
Identifier Type: -
Identifier Source: org_study_id