Clinical trial NCT01303523: Evaluation of the Prevention of Thromboembolic Disease in Patients With a Lower Limb Trauma, Non Surgical, in Winter Sports Resort
Official title: Evaluation of the Prevention of Thromboembolic Disease in Patients With a Lower Limb Trauma, Non Surgical, in Winter Sports Resort.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leg Injuries
Winter Sport Resorts
Outpatients
Keywords: LMWH
heparin
immobilization
anticoagulant prophylaxis
leg injuries
thromboembolism
Lead sponsor: Floralis
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Grenoble
First posted: 2011-02-24
Enrollment: 1627
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatients with a lower limb trauma, in winter sports resorts

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: impact of a thromboembolic disease and heparin's complications
timeFrame: 3 months
Secondary outcomes:
measure: compliance with the algorithm for prescribing heparin and consequences on the primary endpoint
timeFrame: 3 months
measure: incidence of thromboembolic diseases and heparin complications in different subgroups
timeFrame: 3 months
measure: Description of the included patients
timeFrame: evaluation during inclusion visit
measure: Epidemiological characteristics of patients with a thromboembolic event or an adverse effect of the treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Autrans
country: France
facility: medical center "Le chevreuil"
city: Avoriaz
country: France
facility: Medical center "le pas du lac"
city: Bellevaux
country: France
facility: Medical center "les Soldanelles"
city: Chantemerle
country: France
facility: Medical center "le serre d'aigle"
city: Combloux
country: France
facility: Medical center of Combloux
city: Flaine
country: France
facility: Medical home
city: Flumet
country: France
facility: Medical center of flumet
city: Font Romeu
country: France
facility: Medical Center Brousse
city: La Clusaz
country: France
facility: Medical center of Beauregard - "les cyclamens"
city: La Clusaz
country: France
facility: Medical group "le Yéti"
city: Lanslevillard
country: France
facility: Medical center
city: Le Grand Bornand
country: France
facility: Medical group "SELARL Sports médecine montagne"
city: Les Angles
country: France
facility: Medical group of Peric
city: Les Arcs
country: France
facility: Medical center of "Aiguille rouge"
city: Les Contamines
country: France
facility: Medical center "Val Montjoie"
city: Les Gets
country: France
facility: SCP medical "le Bennevy"
city: Les Orres
country: France
facility: Medical center
city: Lullin
country: France
facility: Medical center
city: Megève
country: France
facility: Medical center of Jaillet
city: Peisey Vallandry
country: France
facility: Medical center of Peisey-Vallandry
city: Peyragudes
country: France
facility: Resort of Peyragudes
city: Saint Gervais Les Bains
country: France
facility: Medical center "Fleur des alpes"
city: Samoens
country: France
facility: Medical center
city: St François Longchamp
country: France
facility: Medical center "le rocher de l'aigle"
city: Val d'isère
country: France
facility: Medical center "medival"
city: Valberg Guillaumes
country: France
facility: Medical center of Valberg
city: Vallouise
country: France
facility: Medical center
city: Villard de Lans
country: France
facility: Medical center
Study officials:
affiliation: Médecins de Montagne
name: Dominique LAMY, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.