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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Floralis.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University Hospital, Grenoble
Information provided by:
Floralis
ClinicalTrials.gov Identifier:
NCT01303523
First received: February 23, 2011
Last updated: May 27, 2011
Last verified: May 2011
  Purpose

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.


Condition
Leg Injuries
Winter Sport Resorts
Outpatients

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Prevention of Thromboembolic Disease in Patients With a Lower Limb Trauma, Non Surgical, in Winter Sports Resort.

Resource links provided by NLM:


Further study details as provided by Floralis:

Primary Outcome Measures:
  • impact of a thromboembolic disease and heparin's complications [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • compliance with the algorithm for prescribing heparin and consequences on the primary endpoint [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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.


  • incidence of thromboembolic diseases and heparin complications in different subgroups [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Analysis of subgroups depending on the trauma type, the type of immobilization or not, risk factors of thromboembolic diseases, rolling step and weight bearing.

  • Description of the included patients [ Time Frame: evaluation during inclusion visit ] [ Designated as safety issue: No ]
    epidemiological description of included patients (age, sex, travel time...)

  • Epidemiological characteristics of patients with a thromboembolic event or an adverse effect of the treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 1630
Study Start Date: December 2010
Estimated Study Completion Date: July 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

outpatients with a lower limb trauma, in winter sports resorts

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303523

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

Publications:

Responsible Party: LAMY Dominique, Médecins de Montagne
ClinicalTrials.gov Identifier: NCT01303523     History of Changes
Other Study ID Numbers: DCIC
Study First Received: February 23, 2011
Last Updated: May 27, 2011
Health Authority: France: French Data Protection Authority

Keywords provided by Floralis:
LMWH
heparin
immobilization
anticoagulant prophylaxis
leg injuries
thromboembolism

Additional relevant MeSH terms:
Thromboembolism
Leg Injuries
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014