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

Completed

• Conditions: Winter Sport Resorts; Outpatients; Leg Injuries

• Registration Number: NCT01303523
• Lead Sponsor: Floralis

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 Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-02-23
• Study First Submitted QC: 2011-02-23
• Study First Posted: 2011-02-24
• Primary Completion: 2011-03
• Study Completion: 2011-07
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-05
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1627

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (23)

medical center "Le chevreuil"; 🇫🇷 Autrans, France

Medical center "le pas du lac"; 🇫🇷 Avoriaz, France

Medical center "les Soldanelles"; 🇫🇷 Bellevaux, France

Medical center "le serre d'aigle"; 🇫🇷 Chantemerle, France

Medical center of Combloux; 🇫🇷 Combloux, France

Medical home; 🇫🇷 Flaine, France

Medical center of flumet; 🇫🇷 Flumet, France

Medical Center Brousse; 🇫🇷 Font Romeu, France

Medical center of Beauregard - "les cyclamens"; 🇫🇷 La Clusaz, France

Medical group "le Yéti"; 🇫🇷 La Clusaz, France

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