Evaluation of the Prevention of Thromboembolic Disease in Patients With a Lower Limb Trauma, Non Surgical, in Winter Sports Resort.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Floralis
- Enrollment
- 1,627
- Locations
- 23
- Primary Endpoint
- impact of a thromboembolic disease and heparin's complications
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients seen during a consultation with a physician of mountain
- •lower limb trauma seen within 48 hours
- •patient resident in France
Exclusion Criteria
- •conditions requiring an immediate hospitalization
- •prisoners
- •pregnant, nursing or parturient woman
- •refused participation in follow-up
Outcomes
Primary Outcomes
impact of a thromboembolic disease and heparin's complications
Time Frame: 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.
Secondary Outcomes
- 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)