Clinical trial NCT01501175: Incidence of Superficial Vein Thrombosis
Official title: Evaluation of Annual Incidence of Superficial Vein Thrombosis in the Legs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Superficial Vein Thrombosis
Keywords: superficial vein thrombosis
Saint Etienne region
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2011-12-29
Enrollment: 848
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with suspected SVT inhabitant of the Saint Etienne region

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: symptomatic SVT
timeFrame: 1 year
Secondary outcomes:
measure: SVT risk factors
timeFrame: 1 year
measure: SVT Clinical signs
timeFrame: 1 year
Other outcomes:
Locations:
city: Firminy
country: France
facility: Cabinet D'Angiologie
city: Firminy
country: France
facility: Ch Firminy
city: Saint Chamond
country: France
facility: Cabinet D'Angiologie
city: Saint Etienne
country: France
facility: Cabinet D'Angiologie
city: Saint-chamond
country: France
facility: Centre médical de Chavannes
city: Saint-etienne
country: France
facility: Cabinet D'Angiologie
city: Saint-etienne
country: France
facility: Chu Saint-Etienne
city: Saint-etienne
country: France
facility: Clinique Mutualiste CHirurgicale de St-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Hervé DECOUSUS, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Saint-Etienne
name: Paul FRAPPE, MD
role: STUDY_DIRECTOR
affiliation: CHU de Saint Etienne
name: Bernard TARDY, MD PhD
role: STUDY_DIRECTOR
References: