Evaluation of the Prevention of Thromboembolic Disease in Patients With a Lower Limb Trauma, Non Surgical, in Winter Sports Resort (M2M-Thrombose)

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

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.

Study Overview

• Status: Completed
• Conditions: Leg Injuries; Outpatients; Winter Sport Resorts

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 Type: Observational
• Enrollment (Actual): 1627

Contacts and Locations

Study Locations

• France
  • Autrans, France, 38880
    • medical center "Le chevreuil"
  • Avoriaz, France, 74110
    • Medical center "le pas du lac"
  • Bellevaux, France, 74470
    • Medical center "les Soldanelles"
  • Chantemerle, France, 05330
    • Medical center "le serre d'aigle"
  • Combloux, France, 74920
    • Medical center of Combloux
  • Flaine, France, 74300
    • Medical home
  • Flumet, France, 73590
    • Medical center of flumet
  • Font Romeu, France, 66120
    • Medical Center Brousse
  • La Clusaz, France, 74220
    • Medical center of Beauregard - "les cyclamens"
  • La Clusaz, France, 74220
    • Medical group "le Yéti"
  • Lanslevillard, France, 73480
    • Medical Center
  • Le Grand Bornand, France, 74450
    • Medical group "SELARL Sports médecine montagne"
  • Les Angles, France, 66210
    • Medical group of Peric
  • Les Arcs, France, 73700
    • Medical center of "Aiguille rouge"
  • Les Contamines, France, 74170
    • Medical center "Val Montjoie"
  • Les Gets, France, 74260
    • SCP medical "le Bennevy"
  • Les Orres, France, 05200
    • Medical Center
  • Lullin, France, 74470
    • Medical Center
  • Megève, France, 74120
    • Medical center of Jaillet
  • Peisey Vallandry, France, 73210
    • Medical center of Peisey-Vallandry
  • Peyragudes, France, 65240
    • Resort of Peyragudes
  • Saint Gervais Les Bains, France, 74170
    • Medical center "Fleur des alpes"
  • Samoens, France, 74340
    • Medical Center
  • St François Longchamp, France, 73130
    • Medical center "le rocher de l'aigle"
  • Val d'isère, France, 73150
    • Medical center "medival"
  • Valberg Guillaumes, France, 06470
    • Medical center of Valberg
  • Vallouise, France, 05290
    • Medical Center
  • Villard de Lans, France, 38250
    • Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

outpatients with a lower limb trauma, in winter sports resorts

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3 months
Description of the included patients	epidemiological description of included patients (age, sex, travel time...)	evaluation during inclusion visit
Epidemiological characteristics of patients with a thromboembolic event or an adverse effect of the treatment		3 months

Collaborators and Investigators

• Sponsor: Floralis
• Collaborators: University Hospital, Grenoble
• Investigators: Principal Investigator: Dominique LAMY, MD, Médecins de Montagne

Publications and helpful links

General Publications

• Cohen AT, Davidson BL, Gallus AS, Lassen MR, Prins MH, Tomkowski W, Turpie AG, Egberts JF, Lensing AW; ARTEMIS Investigators. Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial. BMJ. 2006 Feb 11;332(7537):325-9. doi: 10.1136/bmj.38733.466748.7C. Epub 2006 Jan 26.
• 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. doi: 10.1023/a:1018770712660. No abstract available.
• 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. doi: 10.1093/ajhp/58.suppl_2.S4.
• 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.
• 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. doi: 10.1055/s-2007-996071.
• Eschwege V, Robert A. Strikes in French public transport and resistance to activated protein C. Lancet. 1996 Jan 20;347(8995):206. doi: 10.1016/s0140-6736(96)90393-1. No abstract available.
• 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. doi: 10.1191/1358863x02vm449oa.
• 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. doi: 10.1159/000216905.
• Jorgensen 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, Torholm C, Wille-Jorgensen 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. doi: 10.1016/s0049-3848(02)00059-2.
• 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. doi: 10.1056/NEJMoa011327.
• 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. doi: 10.1016/j.ajem.2006.09.012.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: February 23, 2011
• First Submitted That Met QC Criteria: February 23, 2011
• First Posted (Estimate): February 24, 2011

Study Record Updates

• Last Update Posted (Estimate): March 6, 2015
• Last Update Submitted That Met QC Criteria: March 5, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: thromboembolism; heparin; LMWH; immobilization; anticoagulant prophylaxis; leg injuries
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Wounds and Injuries; Embolism and Thrombosis; Thromboembolism; Leg Injuries
• Other Study ID Numbers: DCIC