Leg Injuries, Outpatients, Winter Sport Resorts
Conditions
Keywords
LMWH, heparin, immobilization, anticoagulant prophylaxis, leg injuries, thromboembolism
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.
Interventions
None listed
Sponsors
University Hospital, Grenoble
Floralis
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| impact of a thromboembolic disease and heparin's complications | 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
| Measure | Time frame | Description |
|---|---|---|
| compliance with the algorithm for prescribing heparin and consequences on the primary endpoint | 3 months | The primary endpoint consists to check the impact of thromboembolic disease and adverse effects of anticoagulant therapy at 3 month. We compare the link between these consequences and the compliance with the algorithm about the indication of LMWH therapy. |
| incidence of thromboembolic diseases and heparin complications in different subgroups | 3 months | Analysis of subgroups depending on the trauma type, the type of immobilization or not, risk factors of thromboembolic diseases, rolling step and weight bearing. |
| Description of the included patients | evaluation during inclusion visit | epidemiological description of included patients (age, sex, travel time...) |
| Epidemiological characteristics of patients with a thromboembolic event or an adverse effect of the treatment | 3 months | — |
Countries
France
Outcome results
None listed