M2M-Thrombose: Evaluation of the Prevention of Thromboembolic Disease in Patients With a Lower Limb Trauma, Non Surgical, in Winter Sports Resort
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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patients seen during a consultation with a physician of mountain
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lower limb trauma seen within 48 hours
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patient resident in France
Exclusion Criteria:
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conditions requiring an immediate hospitalization
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prisoners
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pregnant, nursing or parturient woman
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refused participation in follow-up
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | medical center "Le chevreuil" | Autrans | France | 38880 | |
| 2 | Medical center "le pas du lac" | Avoriaz | France | 74110 | |
| 3 | Medical center "les Soldanelles" | Bellevaux | France | 74470 | |
| 4 | Medical center "le serre d'aigle" | Chantemerle | France | 05330 | |
| 5 | Medical center of Combloux | Combloux | France | 74920 | |
| 6 | Medical home | Flaine | France | 74300 | |
| 7 | Medical center of flumet | Flumet | France | 73590 | |
| 8 | Medical Center Brousse | Font Romeu | France | 66120 | |
| 9 | Medical center of Beauregard - "les cyclamens" | La Clusaz | France | 74220 | |
| 10 | Medical group "le Yéti" | La Clusaz | France | 74220 | |
| 11 | Medical center | Lanslevillard | France | 73480 | |
| 12 | Medical group "SELARL Sports médecine montagne" | Le Grand Bornand | France | 74450 | |
| 13 | Medical group of Peric | Les Angles | France | 66210 | |
| 14 | Medical center of "Aiguille rouge" | Les Arcs | France | 73700 | |
| 15 | Medical center "Val Montjoie" | Les Contamines | France | 74170 | |
| 16 | SCP medical "le Bennevy" | Les Gets | France | 74260 | |
| 17 | Medical center | Les Orres | France | 05200 | |
| 18 | Medical center | Lullin | France | 74470 | |
| 19 | Medical center of Jaillet | Megève | France | 74120 | |
| 20 | Medical center of Peisey-Vallandry | Peisey Vallandry | France | 73210 | |
| 21 | Resort of Peyragudes | Peyragudes | France | 65240 | |
| 22 | Medical center "Fleur des alpes" | Saint Gervais Les Bains | France | 74170 | |
| 23 | Medical center | Samoens | France | 74340 | |
| 24 | Medical center "le rocher de l'aigle" | St François Longchamp | France | 73130 | |
| 25 | Medical center "medival" | Val d'isère | France | 73150 | |
| 26 | Medical center of Valberg | Valberg Guillaumes | France | 06470 | |
| 27 | Medical center | Vallouise | France | 05290 | |
| 28 | Medical center | Villard de Lans | France | 38250 |
Sponsors and Collaborators
- Floralis
- University Hospital, Grenoble
Investigators
- Principal Investigator: Dominique LAMY, MD, Médecins de Montagne
Study Documents (Full-Text)
None provided.More Information
Publications
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- Edelsberg J, Ollendorf D, Oster G. Venous thromboembolism following major orthopedic surgery: review of epidemiology and economics. Am J Health Syst Pharm. 2001 Nov 1;58 Suppl 2:S4-13. Review.
- Eschwège V, Robert A. Strikes in French public transport and resistance to activated protein C. Lancet. 1996 Jan 20;347(8995):206.
- Gensini GF, Prisco D, Falciani M, Comeglio M, Colella A. Identification of candidates for prevention of venous thromboembolism. Semin Thromb Hemost. 1997;23(1):55-67. Review.
- Jørgensen PS, Warming T, Hansen K, Paltved C, Vibeke Berg H, Jensen R, Kirchhoff-Jensen R, Kjaer L, Kerbouche N, Leth-Espensen P, Narvestad E, Rasmussen SW, Sloth C, Tørholm C, Wille-Jørgensen P. Low molecular weight heparin (Innohep) as thromboprophylaxis in outpatients with a plaster cast: a venografic controlled study. Thromb Res. 2002 Mar 15;105(6):477-80.
- Kujath P, Spannagel U, Habscheid W. Incidence and prophylaxis of deep venous thrombosis in outpatients with injury of the lower limb. Haemostasis. 1993 Mar;23 Suppl 1:20-6.
- Lassen MR, Borris LC, Nakov RL. Use of the low-molecular-weight heparin reviparin to prevent deep-vein thrombosis after leg injury requiring immobilization. N Engl J Med. 2002 Sep 5;347(10):726-30.
- Lijfering WM, Rosendaal FR, Cannegieter SC. Risk factors for venous thrombosis - current understanding from an epidemiological point of view. Br J Haematol. 2010 Jun;149(6):824-33. doi: 10.1111/j.1365-2141.2010.08206.x. Epub 2010 Apr 29. Review.
- Motykie GD, Zebala LP, Caprini JA, Lee CE, Arcelus JI, Reyna JJ, Cohen EB. A guide to venous thromboembolism risk factor assessment. J Thromb Thrombolysis. 2000 Apr;9(3):253-62. Review.
- Riou B, Rothmann C, Lecoules N, Bouvat E, Bosson JL, Ravaud P, Samama CM, Hamadouche M. Incidence and risk factors for venous thromboembolism in patients with nonsurgical isolated lower limb injuries. Am J Emerg Med. 2007 Jun;25(5):502-8.
- Vaitkus PT, Leizorovicz A, Goldhaber SZ; PREVENT Investigator Group. Rationale and design of a clinical trial of a low-molecular-weight heparin in preventing clinically important venous thromboembolism in medical patients: the prospective evaluation of dalteparin efficacy for prevention of venous thromboembolism in immobilized patients trial (the PREVENT study). Vasc Med. 2002;7(4):269-73.
- DCIC