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Completed

NCT Number: NCT01501175

Incidence of Superficial Vein Thrombosis

To date, the investigators still do not know the annual incidence of Superficial Vein Thrombosis in the legs, although the investigators do know that this pathology is frequent and the investigators can assume its incidence is greater than Deep Vein Thrombosis which is of 1 to 2 cases per year per 1,000 inhabitants. Furthermore, the high percentage of SVT with concomitant DVT and Pulmonary Embolism only concerns patients seen in vascular medicine, so it is important to re-evaluate this rate on an unselected population from general practice.

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Key information

Conditions

Superficial Vein Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cabinet D'Angiologie, Firminy, France

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About this study

The method is a prospective observational study involving all the general practitioners and vascular physicians of the Saint Etienne region, i.e. 276 general practitioners, 27 vascular physicians and 341,822 inhabitants. Any new case of symptomatic SVT in the legs suspected by the general practitioner and confirmed by compression ultrasonography by the vascular physician would be listed over one year. The confirmed SVTs, directly seen by the vascular physicians would also be listed. The incidence would be calculated by relating the total number of SVTs observed to the number of inhabitants of the Saint Etienne region. Information on whether concomitant DVT exists or not at the time of the compression ultrasonography would also be collected.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • inhabitants of the Saint Etienne region
  • with suspected SVT
  • consulting general practitioners and or vascular physicians of the Saint Etienne region

Exclusion criteria

  • SVT not confirmed by compression ultrasonography

Treatment and study plan

consultation with a vascular physician

Other

As in usual practice, patient with suspected SVT will consult a vascular physician to diagnose SVT and eventually DVP/PE associated. Vascular physician will collect risk factors of SVT.

Primary outcomes

  1. symptomatic SVT

    Time frame: 1 year

    new case of symptomatic SVT in the legs suspected by the general practitioner and confirmed by compression ultrasonography by the vascular physician

Secondary outcomes

  1. SVT risk factors

    Time frame: 1 year

    SVT risk factors will be collected during consultation with vascular physician. They are: varicose veins, history of thromboembolism, autoimmune disease,cancer, immobilization, recent surgery

  2. SVT Clinical signs

    Time frame: 1 year

    SVT clinical signs will be collected during consultation with general practitioner and or vascular physician. They are: palpable cords, pain, erythematous area and surrounding edema.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

Evaluation of Annual Incidence of Superficial Vein Thrombosis in the Legs

Acronym: STEPH

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Dec 29, 2011
Registry last updated
Feb 13, 2013

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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