Evaluation of the Prevention of Thromboembolic Disease in Patients With a Lower Limb Trauma, Non Surgical, in Winter Sports Resort.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Floralis
- 入组人数
- 1,627
- 试验地点
- 23
- 主要终点
- impact of a thromboembolic disease and heparin's complications
研究概览
简要总结
The purpose of this study is to evaluate the impact of thromboembolic diseases and heparin complications in patients with a lower limb trauma supported by physicians of mountain.
详细描述
The "M2M-thrombose" study is a prospective epidemiological multicenter study involving patients with a lower limb trauma in winter sport resorts. The following initial data required are type of immobilization, treatment with LMWH (Low Molecular Weight Heparin), type of injury (serious or not) and the rolling of the step (normal or abnormal) or no weight bearing.
A 3 month follow-up by phone will be realized by the Investigation Clinical Center in Grenoble. Data about risk factors of thromboembolic diseases, anticoagulant therapy, medical history, new event since inclusion (hospitalization, surgery, lower limb trauma or thromboembolic events) will be collected.
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
- •patients seen during a consultation with a physician of mountain
- •lower limb trauma seen within 48 hours
- •patient resident in France
排除标准
- •conditions requiring an immediate hospitalization
- •prisoners
- •pregnant, nursing or parturient woman
- •refused participation in follow-up
结局指标
主要结局
impact of a thromboembolic disease and heparin's complications
时间窗: 3 months
Evaluation of the impact of a thromboembolic disease and heparin's complications in outpatients with a lower limb trauma are supported by physicians in winter sports resort. The patients will be contacted by phone 3 months after trauma to collect these data.
次要结局
- Description of the included patients(evaluation during inclusion visit)
- Epidemiological characteristics of patients with a thromboembolic event or an adverse effect of the treatment(3 months)
- compliance with the algorithm for prescribing heparin and consequences on the primary endpoint(3 months)
- incidence of thromboembolic diseases and heparin complications in different subgroups(3 months)