Deep Venous Thrombosis and Risk of Long Term Complications in Acutely Admitted Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Change in suPAR - 24 months
研究概览
简要总结
In this cohort study, the investigators will investigate the concentration of biomarkers, e.g., inflammatory, anti-inflammatory, immunological, senescent, biochemical ratio-calculations, blood cell type, and and long term complications with a 2-year follow-up in patients with first time lower extremity deep venous thrombosis
详细描述
Venous thromboembolism (VTE), which is a common concept for deep venous thrombosis (DVT) and pulmonary embolus (PE), is the third most common cardiovascular disease after myocardial infarction and stroke. The incidence of deep venous thrombosis (DVT) increases exponentially with age and is highest in high-income countries compared to low-income countries. The pathophysiology of DVT is of multicomplex aetiology and there are multifactorial causes leading to the development of DVT. In the long term, patients with DVT can experience reduced thrombus resolution, recurrent thrombosis, and post thrombotic syndrome (PTS), where inflammation has a major impact.
The investigators hypotheses are:
There is an increased level of biomarkers at time of diagnosis among DVT patients who develop PTS compared to DVT patients who do not develop PTS
Purpose:
In this clinical prospective cohort study the investigators will investigate and characterize acutely admitted patients with deep venous thrombosis via inflammatory, anti-inflammatory, immunological and ageing biomarkers to gain a better understanding of options about prevention and treatment of long-term complications
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or above
- •First time lower extremity DVT
- •Hospitalized at the Emergency Department
排除标准
- •Patients without a Danish social security number
- •Terminal patients
- •Patients who do not understand or speak Danish
研究组 & 干预措施
Biomarkers and long term complications in DVT patients
Patients with DVT will be enrolled in the study during their hospitalization at the ED. The enrolled patients will have 4 follow-up visits, 1) during the first 14 days after diagnosis, 2) after 3 months, 3) after 12 months and 4) 24 months after the time of diagnosis.
干预措施: Blood sample and Ultrasound examination (Diagnostic Test)
结局指标
主要结局
Change in suPAR - 24 months
时间窗: 24 months
Change in suPAR level in first-time DVT patients from the time of diagnosis (baseline) to 24 months
Association of suPAR and PTS - 90 days
时间窗: 90 days
Association of suPAR and development of PTS in DVT patients from the time of diagnosis and 90 days after diagnosis
次要结局
- Change in suPAR - 90 days(90 days)
- Change in suPAR - 12 months(12 months)
- Prevalence of PTS in DVT patients - 90 days(90 days)
- Prevalence of PTS in DVT patients - 12 months(12 months)
- Prevalence of PTS in DVT patients - 24 months(24 months)
- Association of suPAR and PTS - 12 month(12 months)
- Association of suPAR and PTS - 24 month(24 months)
- Change in suPAR in patients with prior sars-CoV-2 infection - 24 months(24 months)
- Association of suPAR and PTS in patients with prior sars-CoV-2 infection - 90 days(90 days)
研究者
Ove Andersen
Research Director and Head of the Department of Clinical Research
Hvidovre University Hospital