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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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.

Detailed Summary:

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.


Sponsor: Floralis

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.

  • 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.
  • Description of the included patients [ Time Frame: evaluation during inclusion visit ]
    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 ]


Original Secondary Outcome: Same as current

Information By: Floralis

Dates:
Date Received: February 23, 2011
Date Started: December 2010
Date Completion:
Last Updated: March 5, 2015
Last Verified: March 2015