Evaluation of the Prevention of Thromboembolic Disease in Patients With a Lower Limb Trauma, Non Surgical, in Winter Sports Resort (M2M-Thrombose)
|ClinicalTrials.gov Identifier: NCT01303523|
Recruitment Status : Completed
First Posted : February 24, 2011
Last Update Posted : March 6, 2015
|Condition or disease|
|Leg Injuries Winter Sport Resorts Outpatients|
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|
|Actual Enrollment :||1627 participants|
|Official Title:||Evaluation of the Prevention of Thromboembolic Disease in Patients With a Lower Limb Trauma, Non Surgical, in Winter Sports Resort.|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||July 2011|
- 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.
- compliance with the algorithm for prescribing heparin and consequences on the primary endpoint [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01303523
|Principal Investigator:||Dominique LAMY, MD||Médecins de Montagne|