Clinical trial NCT04400877: Prevalence and Severity of Venous Thromboembolism in a General Population During the COVID-19 Pandemic
Official title: Prevalence and Severity of Venous Thromboembolism in a General Population During the COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Venous Thromboembolism
Pulmonary Embolism
Deep Vein Thrombosis
SARS-CoV 2
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2020-05-26
Enrollment: 7795
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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.

Eligibility 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

Primary outcomes:
measure: Is there an increased prevalence of venous thromboembolism in a regional healthcare system in Sweden during the SARS-CoV-2 pandemic?
timeFrame: March to May in 2020
measure: Is a SARS-CoV-2-infection an isolated risk factor for thromboembolism?
timeFrame: March to May in 2020
Secondary outcomes:
measure: Are there geographic differences in the prevalence of venous thromboembolism within the healthcare system?
timeFrame: March to May in 2020
measure: Is venous thromboembolism associated with increased mortality adjusted for relevant comorbidities?
timeFrame: March to May in 2020
measure: How long is the time between symptom onset of the SARS-CoV-2-infection and any subsequent venous thromboembolism?
timeFrame: March to May in 2020
measure: Is treatment with prophylactic antithrombotic or anticoagulant treatment associated with increased survival?
timeFrame: March to May in 2020
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: University Hospital Linköping
state: Östergötland
Study officials:
affiliation: Emergency Department, University Hospital Linköping, Sweden
name: Jens Wretborn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emergency Department, University Hospital Linköping, Sweden
name: Patrik Benjaminsson Nyberg, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emergency Department, University Hospital Linköping, Sweden
name: Matthias Jörg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.