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Incidence of Superficial Vein Thrombosis (STEPH)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01501175
First received: December 27, 2011
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Superficial Vein Thrombosis
 Other: consultation with a vascular physician

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation of Annual Incidence of Superficial Vein Thrombosis in the Legs

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • symptomatic SVT [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    new case of symptomatic SVT in the legs suspected by the general practitioner and confirmed by compression ultrasonography by the vascular physician


Secondary Outcome Measures:
  • SVT risk factors [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    SVT risk factors will be collected during consultation with vascular physician. They are: varicose veins, history of thromboembolism, autoimmune disease,cancer, immobilization, recent surgery

  • SVT Clinical signs [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 848
Study Start Date: November 2011
Study Completion Date: January 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with suspected SVT inhabitant of the Saint Etienne region

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501175

Locations
France
Ch Firminy
Firminy, France, 42700
Cabinet D'Angiologie
Firminy, France, 42700
Cabinet D'Angiologie
Saint Chamond, France, 42400
Cabinet D'Angiologie
Saint Etienne, France, 42000
Centre médical de Chavannes
Saint-chamond, France, 42400
Clinique Mutualiste CHirurgicale de St-Etienne
Saint-etienne, France, 42000
Chu Saint-Etienne
Saint-etienne, France, 42000
Cabinet D'Angiologie
Saint-etienne, France, 42000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
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
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01501175     History of Changes
Other Study ID Numbers: 1108036, 11.385
Study First Received: December 27, 2011
Last Updated: February 12, 2013
Health Authority: France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
superficial vein thrombosis
Saint Etienne region

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013