An observational study in Leg Injuries, Winter Sport Resorts and Outpatients, sponsored by Floralis. Completed at 28 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-06.
Sponsored by Floralis · Observational
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.
818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.
This study's enrollment of 1,627 is above the median of 500 across 344 observational studies indexed under Thromboembolism.
Browse Thromboembolism studies →Floralis is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
outpatients with a lower limb trauma, in winter sports resorts
Exclusion Criteria:
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
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
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Floralis