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

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ClinicalTrials.gov Identifier: NCT01303523
Recruitment Status : Completed
First Posted : February 24, 2011
Last Update Posted : March 6, 2015
Sponsor:
Collaborator:
University Hospital, Grenoble
Information provided by (Responsible Party):
Floralis

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.

Condition or disease
Leg Injuries Winter Sport Resorts Outpatients

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.

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Study Type : Observational
Actual Enrollment : 1627 participants
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.
Study Start Date : December 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. impact of a thromboembolic disease and heparin's complications [ Time Frame: 3 months ]
    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 :
  1. compliance with the algorithm for prescribing heparin and consequences on the primary endpoint [ Time Frame: 3 months ]

    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.


  2. incidence of thromboembolic diseases and heparin complications in different subgroups [ Time Frame: 3 months ]
    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. Description of the included patients [ Time Frame: evaluation during inclusion visit ]
    epidemiological description of included patients (age, sex, travel time...)

  4. Epidemiological characteristics of patients with a thromboembolic event or an adverse effect of the treatment [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01303523


Locations
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Sponsors and Collaborators
Floralis
University Hospital, Grenoble
Investigators
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Principal Investigator: Dominique LAMY, MD Médecins de Montagne
Publications:

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Responsible Party: Floralis
ClinicalTrials.gov Identifier: NCT01303523    
Other Study ID Numbers: DCIC
First Posted: February 24, 2011    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015
Keywords provided by Floralis:
LMWH
heparin
immobilization
anticoagulant prophylaxis
leg injuries
thromboembolism
Additional relevant MeSH terms:
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Thromboembolism
Leg Injuries
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries