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临床试验/NCT04400877
NCT04400877已完成不适用

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

University Hospital, Linkoeping1 个研究点 分布在 1 个国家目标入组 7,795 人开始时间: 2020年6月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
7,795
试验地点
1
主要终点
Is there an increased prevalence of venous thromboembolism in a regional healthcare system in Sweden during the SARS-CoV-2 pandemic?

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Is there an increased prevalence of venous thromboembolism in a regional healthcare system in Sweden during the SARS-CoV-2 pandemic?

时间窗: March to May in 2020

Is a SARS-CoV-2-infection an isolated risk factor for thromboembolism?

时间窗: March to May in 2020

次要结局

  • 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)

研究者

发起方
University Hospital, Linkoeping
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Wilhelms

MD, Emergency department head of research

University Hospital, Linkoeping

研究点 (1)

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