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Completed

NCT Number: NCT01303523

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.

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Key information

Conditions

Leg Injuries Cardiovascular Diseases Embolism and Thrombosis Outpatients Thromboembolism Vascular Diseases Winter Sport Resorts Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

medical center "Le chevreuil", Autrans, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Floralis

Industry

Collaborators

  • University Hospital, Grenoble

Registry information

Official study title

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

Acronym: M2M-Thrombose

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 24, 2011
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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