Evaluation of the Prevention of Thromboembolic Disease in Patients With a Lower Limb Trauma, Non Surgical, in Winter Sports Resort

Floralis1,627 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

1,627

Conditions

Leg Injuries Winter Sport Resorts Outpatients

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (28)

medical center "Le chevreuil"

Autrans, France

Outcomes

Primary Outcomes

impact of a thromboembolic disease and heparin's complications

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.

Time frame: 3 months

Secondary Outcomes

compliance with the algorithm for prescribing heparin and consequences on the primary endpoint

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.

Time frame: 3 months

incidence of thromboembolic diseases and heparin complications in different subgroups

Analysis of subgroups depending on the trauma type, the type of immobilization or not, risk factors of thromboembolic diseases, rolling step and weight bearing.

Time frame: 3 months

Description of the included patients

epidemiological description of included patients (age, sex, travel time...)

Time frame: evaluation during inclusion visit

Epidemiological characteristics of patients with a thromboembolic event or an adverse effect of the treatment

Time frame: 3 months

Data from ClinicalTrials.gov

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