The Risk of Venous Thromboembolism in Systemic Inflammatory Disorders: a UK Matched Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 266,890
- 试验地点
- 1
- 主要终点
- Risk of Venous Thromboembolism (VTE)
研究概览
简要总结
Blood clots occurring in the legs and in the lungs are relatively common; they occur in around 3 in a 1000 people per year. They can cause disability and are also potentially life threatening. When a clot occurs in the legs it is called a deep vein thrombosis or DVT. When they occur in the lungs they are called a pulmonary embolism or PE. The risk for DVT and PE is higher in people with conditions which cause inflammation. The most common of these are inflammatory bowel disease (ulcerative colitis and Crohn's disease), rheumatoid arthritis, and psoriatic arthritis (a condition comprised of psoriasis and joint inflammation).
What is not known is how much higher the risk of DVT and PE is in these groups compared with people without inflammatory disease, and what causes the excess risk in these people. This study aims to assess the measure the exact increase in risk for DVT and PE in people with these inflammatory conditions and to identify which risk factors are most strongly associated with the increased risk. These data should help with an understand the causes of blood clot risk in these inflammatory conditions and in identify targets for reducing risk.
详细描述
Background
Venous thromboembolism (VTE), comprising pulmonary embolism (PE) and deep vein thrombosis (DVT), are common and associated with significant morbidity and mortality. VTE risk is higher in chronic inflammatory conditions including inflammatory bowel disease (IBD) and rheumatoid arthritis (RA) compared to the general population. Evidence for differential VTE risk in other inflammatory diseases, notably psoriatic arthritis (PsA) and vasculitis, is more limited. Risk factors for VTE have been described in the general population, but there has been little interrogation of VTE risk factors for individuals with chronic inflammatory conditions and their association with subsequent VTE.
Objective
This study aims to describe the prevalence of VTE risk and risk factors in individuals with systemic inflammatory disorders in a contemporary real-world population, by disease type (IBD, RA, and PsA) and relative to a control population without systemic inflammatory disease. In the same cohorts a further comparison will be performed of the influence of VTE risk factors on risk of VTE events in individuals with systemic inflammatory disorders.
Method
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
- 是
入选标准
- •Adult patients (aged ≥18) contributing to RCGP RCS primary care database between January 1, 1998 and January 1, 2018, will be eligible for inclusion
排除标准
- •People with IBD which cannot be classified or is not ulcerative colitis or Crohn's disease will be excluded.
结局指标
主要结局
Risk of Venous Thromboembolism (VTE)
时间窗: A 20 year analysis period (1999-2018 inclusive)
Number of participants with systemic inflammatory disorders developing VTE (a composite of pulmonary embolism (PE) and deep vein thrombosis (DVT)) compared to population controls.
次要结局
- Risk of Pulmonary Embolism (PE)(A 20 year analysis period (1999-2018 inclusive))
- Risk of Deep Vein Thrombosis (DVT)(A 20 year analysis period (1999-2018 inclusive))