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

Leg Injuries Clinical Trial

— M2M-Thrombose  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01303523
• Other study ID #: DCIC
• Status: Completed
• Phase: N/A
• First received: February 23, 2011
• Last updated: March 5, 2015
• Start date: December 2010
• Est. completion date: July 2011

Study information

• Verified date: March 2015
• Source: Floralis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1627
• Est. completion date: July 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leg Injuries
• Outpatients
• Thromboembolism
• Winter Sport Resorts

Locations

Country	Name	City	State
France	medical center "Le chevreuil"	Autrans
France	Medical center "le pas du lac"	Avoriaz
France	Medical center "les Soldanelles"	Bellevaux
France	Medical center "le serre d'aigle"	Chantemerle
France	Medical center of Combloux	Combloux
France	Medical home	Flaine
France	Medical center of flumet	Flumet
France	Medical Center Brousse	Font Romeu
France	Medical center of Beauregard - "les cyclamens"	La Clusaz
France	Medical group "le Yéti"	La Clusaz
France	Medical center	Lanslevillard
France	Medical group "SELARL Sports médecine montagne"	Le Grand Bornand
France	Medical group of Peric	Les Angles
France	Medical center of "Aiguille rouge"	Les Arcs
France	Medical center "Val Montjoie"	Les Contamines
France	SCP medical "le Bennevy"	Les Gets
France	Medical center	Les Orres
France	Medical center	Lullin
France	Medical center of Jaillet	Megève
France	Medical center of Peisey-Vallandry	Peisey Vallandry
France	Resort of Peyragudes	Peyragudes
France	Medical center "Fleur des alpes"	Saint Gervais Les Bains
France	Medical center	Samoens
France	Medical center "le rocher de l'aigle"	St François Longchamp
France	Medical center "medival"	Val d'isère
France	Medical center of Valberg	Valberg Guillaumes
France	Medical center	Vallouise
France	Medical center	Villard de Lans

Sponsors (2)

Lead Sponsor	Collaborator
Floralis	University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (11)

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. Epub 2006 Jan 26. — View 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. Review. — View Citation

Eschwège V, Robert A. Strikes in French public transport and resistance to activated protein C. Lancet. 1996 Jan 20;347(8995):206. — View 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. Review. — View Citation

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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Description of the included patients	epidemiological description of included patients (age, sex, travel time...)	evaluation during inclusion visit	No
Secondary	Epidemiological characteristics of patients with a thromboembolic event or an adverse effect of the treatment		3 months	No