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

NCT04400877 | Completed

• 1 other identifier: SE2020-02701
• Study Type: observational
• Target: 7,795
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

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

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

Interventions

Diagnostic examination for venous thromboembolism DIAGNOSTIC_TEST

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.

Also known as: CT Pulmonary Angiogram (CTPA), Ultrasound for deep venous thrombosis (DVT)

SARS-CoV-2 neg; SARS-CoV-2 pos

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Linkoeping: lead

Study Sites (1)

University Hospital Linköping

Linköping, Östergötland County, 58185, Sweden

Location

Related Publications (11)

• 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.

  PMID: 11138871 BACKGROUND

• 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.

  PMID: 16003063 BACKGROUND

• 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.

  PMID: 32271988 BACKGROUND

• 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.

  PMID: 32367170 BACKGROUND

• 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.

  PMID: 26111103 BACKGROUND

• 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.

  PMID: 32291094 BACKGROUND

• 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.

  PMID: 32324102 BACKGROUND

• 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.

  PMID: 18086398 BACKGROUND

• 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.

  PMID: 32330083 BACKGROUND

• 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.

  PMID: 32338827 BACKGROUND

• 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.

  PMID: 37015984 DERIVED

Related Links

• Complete study protocol as used for approval at the Swedish Ethical Review Authority

MeSH Terms

Conditions

COVID-19; Venous Thromboembolism; Pulmonary Embolism; Venous Thrombosis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Embolism; Thrombosis

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Emergency department head of research

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 26, 2020
• Study Start: June 8, 2020
• Primary Completion: July 30, 2020
• Study Completion: September 30, 2020
• Last Updated: November 18, 2021

Record last verified: 2021-11

Locations

SE (1)