AzTrials
AzTrials

Leg InjuriesM2M-ThromboseNCT01303523

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

An observational study of Leg Injuries and Winter Sport Resorts, run by Floralis at 28 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leg Injuries, Winter Sport Resorts, Outpatients
How many people
1,627 participants
Where
28 sitesFrance
Study dates
Dec 2010to Jul 2011
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: outpatients with a lower limb trauma, in winter sports resorts

Who may be able to join

  • patients seen during a consultation with a physician of mountain
  • lower limb trauma seen within 48 hours
  • patient resident in France

Who cannot join

  • conditions requiring an immediate hospitalization
  • prisoners
  • pregnant, nursing or parturient woman
  • refused participation in follow-up

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

France28 sites

  • medical center "Le chevreuil"

    Autrans, 38880

  • Medical center "le pas du lac"

    Avoriaz, 74110

  • Medical center "les Soldanelles"

    Bellevaux, 74470

  • Medical center "le serre d'aigle"

    Chantemerle, 05330

  • Medical center of Combloux

    Combloux, 74920

  • Medical home

    Flaine, 74300

  • Medical center of flumet

    Flumet, 73590

  • Medical Center Brousse

    Font-Romeu-Odeillo-Via, 66120

  • Medical center of Beauregard - "les cyclamens"

    La Clusaz, 74220

  • Medical group "le Yéti"

    La Clusaz, 74220

  • Medical center

    Lanslevillard, 73480

  • Medical group "SELARL Sports médecine montagne"

    Le Grand-Bornand, 74450

  • Medical group of Peric

    Les Angles, 66210

  • Medical center of "Aiguille rouge"

    Les Arcs, 73700

  • Medical center "Val Montjoie"

    Les Contamines-Montjoie, 74170

  • SCP medical "le Bennevy"

    Les Gets, 74260

  • Medical center

    Les Orres, 05200

  • Medical center

    Lullin, 74470

  • Medical center of Jaillet

    Megève, 74120

  • Medical center of Peisey-Vallandry

    Peisey Vallandry, 73210

  • Resort of Peyragudes

    Peyragudes, 65240

  • Medical center "le rocher de l'aigle"

    Saint-François-Longchamp, 73130

  • Medical center "Fleur des alpes"

    Saint-Gervais-les-Bains, 74170

  • Medical center

    Samoëns, 74340

  • Medical center "medival"

    Val-d'Isère, 73150

  • Medical center of Valberg

    Valberg Guillaumes, 06470

  • Medical center

    Vallouise, 05290

  • Medical center

    Villard-de-Lans, 38250

Other trials in France

About this study

Official title: 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.

Read the 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.

Keywords
LMWH, heparin, immobilization, anticoagulant prophylaxis, leg injuries, thromboembolism
Medical subject headings
Leg Injuries, Thromboembolism

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

Secondary outcomes (4)

  1. 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.

    Measured: 3 months

  2. 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.

    Measured: 3 months

  3. Description of the included patients

    epidemiological description of included patients (age, sex, travel time...)

    Measured: evaluation during inclusion visit

  4. Epidemiological characteristics of patients with a thromboembolic event or an adverse effect of the treatment

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2011 (estimated)
  2. Study startDec 2010
  3. Primary completionMar 2011
  4. Study completionJul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,627 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01303523
Sponsor's protocol ID
DCIC
Acronym
M2M-Thrombose
Status last verified
Mar 2015
First submitted
23 Feb 2011
Last updated
6 Mar 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 10728025

  • 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.

    PubMed 11715837

  • 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.

    PubMed 20456358

  • 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.

    PubMed 9156412

  • 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.

    PubMed 8544587

  • 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.

    PubMed 12710842

  • 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.

    PubMed 16439370

  • 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.

    PubMed 8388353

  • 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.

    PubMed 12091045

  • 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.

    PubMed 12213943

  • 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.

    PubMed 17543652

Questions about this trial

What is this clinical trial studying?

An observational study of Leg Injuries and Winter Sport Resorts, run by Floralis at 28 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

impact of a thromboembolic disease and heparin's complications (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01303523, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in