Evaluation of the Prevention of Thromboembolic Disease in Patients With a Lower Limb Trauma, Non Surgical, in Winter Sports Resort (M2M-Thrombose)
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition |
|---|
|
Leg Injuries Winter Sport Resorts Outpatients |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Evaluation of the Prevention of Thromboembolic Disease in Patients With a Lower Limb Trauma, Non Surgical, in Winter Sports Resort. |
- impact of a thromboembolic disease and heparin's complications [ Time Frame: 3 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
| Enrollment: | 1630 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | July 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
outpatients with a lower limb trauma, in winter sports resorts
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
Contacts and Locations| France | |
| medical center "Le chevreuil" | |
| Autrans, France, 38880 | |
| Medical center "le pas du lac" | |
| Avoriaz, France, 74110 | |
| Medical center "les Soldanelles" | |
| Bellevaux, France, 74470 | |
| Medical center "le serre d'aigle" | |
| Chantemerle, France, 05330 | |
| Medical center of Combloux | |
| Combloux, France, 74920 | |
| Medical home | |
| Flaine, France, 74300 | |
| Medical center of flumet | |
| Flumet, France, 73590 | |
| Medical Center Brousse | |
| Font Romeu, France, 66120 | |
| Medical center of Beauregard - "les cyclamens" | |
| La Clusaz, France, 74220 | |
| Medical group "le Yéti" | |
| La Clusaz, France, 74220 | |
| Medical center | |
| Lanslevillard, France, 73480 | |
| Medical group "SELARL Sports médecine montagne" | |
| Le Grand Bornand, France, 74450 | |
| Medical group of Peric | |
| Les Angles, France, 66210 | |
| Medical center of "Aiguille rouge" | |
| Les Arcs, France, 73700 | |
| Medical center "Val Montjoie" | |
| Les Contamines, France, 74170 | |
| SCP medical "le Bennevy" | |
| Les Gets, France, 74260 | |
| Medical center | |
| Les Orres, France, 05200 | |
| Medical center | |
| Lullin, France, 74470 | |
| Medical center of Jaillet | |
| Megève, France, 74120 | |
| Medical center of Peisey-Vallandry | |
| Peisey Vallandry, France, 73210 | |
| Resort of Peyragudes | |
| Peyragudes, France, 65240 | |
| Medical center "Fleur des alpes" | |
| Saint Gervais Les Bains, France, 74170 | |
| Medical center | |
| Samoens, France, 74340 | |
| Medical center "le rocher de l'aigle" | |
| St François Longchamp, France, 73130 | |
| Medical center "medival" | |
| Val d'isère, France, 73150 | |
| Medical center of Valberg | |
| Valberg Guillaumes, France, 06470 | |
| Medical center | |
| Vallouise, France, 05290 | |
| Medical center | |
| Villard de Lans, France, 38250 | |
| Principal Investigator: | Dominique LAMY, MD | Médecins de Montagne |
More Information
Publications:
| Responsible Party: | LAMY Dominique, Médecins de Montagne |
| ClinicalTrials.gov Identifier: | NCT01303523 History of Changes |
| Other Study ID Numbers: | DCIC |
| Study First Received: | February 23, 2011 |
| Last Updated: | May 27, 2011 |
| Health Authority: | France: French Data Protection Authority |
Keywords provided by Floralis:
|
LMWH heparin immobilization |
anticoagulant prophylaxis leg injuries thromboembolism |
Additional relevant MeSH terms:
|
Leg Injuries Thromboembolism Wounds and Injuries Embolism and Thrombosis |
Vascular Diseases Cardiovascular Diseases Thrombosis |
ClinicalTrials.gov processed this record on June 18, 2013