Incidence of Superficial Vein Thrombosis (STEPH)

Evaluation of Annual Incidence of Superficial Vein Thrombosis in the Legs

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.

Study Overview

• Status: Completed
• Conditions: Superficial Vein Thrombosis
• Intervention / Treatment: Other: consultation with a vascular physician

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.

• Study Type: Observational
• Enrollment (Actual): 848

Contacts and Locations

Study Locations

• France
  • Firminy, France, 42700
    • Cabinet d'Angiologie
  • Firminy, France, 42700
    • Ch Firminy
  • Saint Chamond, France, 42400
    • Cabinet d'Angiologie
  • Saint Etienne, France, 42000
    • Cabinet d'Angiologie
  • Saint-chamond, France, 42400
    • Centre médical de Chavannes
  • Saint-etienne, France, 42000
    • Cabinet d'Angiologie
  • Saint-etienne, France, 42000
    • CHU Saint-Etienne
  • Saint-etienne, France, 42000
    • Clinique Mutualiste CHirurgicale de St-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with suspected SVT inhabitant of the Saint Etienne region

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with suspected SVT; patients with suspected SVT and inhabitants of the Saint Etienne region	Other: consultation with a vascular physician; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
symptomatic SVT	new case of symptomatic SVT in the legs suspected by the general practitioner and confirmed by compression ultrasonography by the vascular physician	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SVT risk factors	SVT risk factors will be collected during consultation with vascular physician. They are: varicose veins, history of thromboembolism, autoimmune disease,cancer, immobilization, recent surgery	1 year
SVT Clinical signs	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.	1 year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Hervé DECOUSUS, MD PhD, CHU Saint-Etienne; Study Director: Paul FRAPPE, MD, University of Saint-Etienne; Study Director: Bernard TARDY, MD PhD, CHU de Saint Etienne

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: December 27, 2011
• First Submitted That Met QC Criteria: December 28, 2011
• First Posted (Estimate): December 29, 2011

Study Record Updates

• Last Update Posted (Estimate): February 13, 2013
• Last Update Submitted That Met QC Criteria: February 12, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: superficial vein thrombosis; Saint Etienne region
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: 1108036; 11.385 (Other Identifier: CCTIRS)