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

NCT ID: NCT01303523

Last Updated: 2015-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1627 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Leg Injuries Winter Sport Resorts Outpatients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Grenoble

OTHER

Sponsor Role collaborator

Floralis

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dominique LAMY, MD

Role: PRINCIPAL_INVESTIGATOR

Médecins de Montagne

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

medical center "Le chevreuil"

Autrans, , France

Site Status

Medical center "le pas du lac"

Avoriaz, , France

Site Status

Medical center "les Soldanelles"

Bellevaux, , France

Site Status

Medical center "le serre d'aigle"

Chantemerle, , France

Site Status

Medical center of Combloux

Combloux, , France

Site Status

Medical home

Flaine, , France

Site Status

Medical center of flumet

Flumet, , France

Site Status

Medical Center Brousse

Font-Romeu-Odeillo-Via, , France

Site Status

Medical center of Beauregard - "les cyclamens"

La Clusaz, , France

Site Status

Medical group "le Yéti"

La Clusaz, , France

Site Status

Medical center

Lanslevillard, , France

Site Status

Medical group "SELARL Sports médecine montagne"

Le Grand-Bornand, , France

Site Status

Medical group of Peric

Les Angles, , France

Site Status

Medical center of "Aiguille rouge"

Les Arcs, , France

Site Status

Medical center "Val Montjoie"

Les Contamines-Montjoie, , France

Site Status

SCP medical "le Bennevy"

Les Gets, , France

Site Status

Medical center

Les Orres, , France

Site Status

Medical center

Lullin, , France

Site Status

Medical center of Jaillet

Megève, , France

Site Status

Medical center of Peisey-Vallandry

Peisey Vallandry, , France

Site Status

Resort of Peyragudes

Peyragudes, , France

Site Status

Medical center "le rocher de l'aigle"

Saint-François-Longchamp, , France

Site Status

Medical center "Fleur des alpes"

Saint-Gervais-les-Bains, , France

Site Status

Medical center

Samoëns, , France

Site Status

Medical center "medival"

Val-d'Isère, , France

Site Status

Medical center of Valberg

Valberg Guillaumes, , France

Site Status

Medical center

Vallouise, , France

Site Status

Medical center

Villard-de-Lans, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 10728025 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11715837 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20456358 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9156412 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8544587 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12710842 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16439370 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8388353 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12091045 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12213943 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17543652 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DCIC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prevention in Volleyball Players
NCT04892121 COMPLETED NA