Cohort for Monitoring Patients With Venous Thromboembolic Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Rate of recurrence in patients treated with venous thromboembolic disease (VTE)
研究概览
简要总结
Venous thromboembolic disease is a common pathology in the general population (1.5/1000), the prognosis of which depends in particular on the risk of recurrence. This risk depends essentially on whether the thrombotic episode was provoked or not. Thus, patients who present a thromboembolic event without any contributing factor have a high risk of recurrence, which encourages clinicians to continue anticoagulant treatment for a long time. However, anticoagulant treatment is the leading cause of hospitalization for iatrogenic causes and the leading cause of iatrogenic mortality. The benefit-risk balance of treatment must be evaluated regularly, which requires a good knowledge of the risk factors for thrombotic recurrence and the risk factors for hemorrhage.
详细描述
Several tools have been established and validated to help clinicians assess patients' bleeding risk, notably using the HAS BLED, haemorrage, and more recently the VTE BLED score. This latest score, published very recently, is the only one to have been validated in patients treated with direct oral anticoagulants. At the same time, we have recurrence risk scores such as HERDOO2, which allow us to identify patients at low risk of recurrence.
In order to improve the management of patients with venous thromboembolic disease, multidisciplinary thrombosis RCPs have been established since 2015, bringing together hemostasis specialists, internists, oncologists, and private vascular physicians to assist clinicians in managing complex cases. • Dedicated post-emergency consultations twice a week to streamline outpatient care for less serious patients This study aims to evaluate the effectiveness of these tools: score and RCP in the management of patients with venous thromboembolic disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Any patient over 18 years of age who has experienced at least one venous thromboembolic episode:
- •Deep vein thrombosis confirmed by Doppler ultrasound or CT venography,
- •Pulmonary embolism confirmed by CT angiography, ventilation/perfusion scan, or confirmed DVT episode with respiratory signs consistent with PE.
- •Hospitalization in the Internal Medicine Department
- •Consultation by an Internal Medicine physician
- •File presented at the thrombosis multidisciplinary meeting
排除标准
- •Thrombosis not meeting the inclusion criteria (cerebral venous thrombosis, mesenteric)
结局指标
主要结局
Rate of recurrence in patients treated with venous thromboembolic disease (VTE)
时间窗: 12 years
Evaluation of the number of hospitalizations or consultations for a venous thrombotic recurrence
Rate of bleeding complications in patients treated with venous thromboembolic disease (VTE)
时间窗: 12 years
Evaluation of the number of hospitalizations or consultations for a hemorrhagic complication.
次要结局
- Long-term complication rates(At enrollment visit, 6 months, 1 years and each year during 12 years)