POST (Prospective Observational Superfial Thrombophlebitis) (POST)

January 12, 2009 updated by: Centre Hospitalier Universitaire de Saint Etienne

Superficial Thrombophlebitis and Venous Thromboembolism: A Large Prospective Epidemiological Study

We performed a national cross-sectional and prospective large epidemiological cohort study in patients with ST. Office- and hospital-based vascular medicine French practitioners enrolled all consecutive patients with a symptomatic ST of the lower limbs at least 5 cm long documented by compression ultrasonography. Follow-up was three months. All events were adjudicated by a central committee.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Between March 2005 and October 2006, 844 patients (median age [range]: 65 [18-98] years; 547 women) were included. At inclusion, confirmed deep-vein thrombosis and/or symptomatic pulmonary embolism was associated with ST in 24.9% (n=210) of patients. Among the 600 patients with isolated ST (i.e. without deep-vein thrombosis or pulmonary embolism at inclusion), 10.4% (n=56) developed venous thromboembolic complications at three months, including the following symptomatic events: pulmonary embolism (0.4%, n=2), deep-vein thrombosis (2.8%, n=15), extension of ST (3.1%, n=17) and recurrence of ST (1.9%, n=10). These complications occurred despite the use of various anticoagulant strategies in 90.5% (n=540) of patients; four independent risk factors increased the risk of these complications: male sex, cardiac or respiratory insufficiency, history of deep-vein thrombosis or pulmonary embolism and no history of varicose veins.

Study Type

Observational

Enrollment (Actual)

844

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Annonay, France, 07100
        • LEANDRI
      • Aubenas, France, 07000
        • CHANUT
      • Bourgoin Jailleu, France, 38000
        • GILLET
      • Caen, France, 34000
        • Barrelier
      • Dieppe, France
        • Guenneguez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 symptomatic ST of the lower limbs.

Description

Inclusion Criteria:

  • all consecutive patients aged 18 years or over, with a symptomatic ST of the lower limbs at least 5 cm long on compression ultrasonography.

Exclusion Criteria:

  • patients who had undergone surgery under general or loco-regional anaesthesia in the previous 10 days, those in whom ST had occurred after sclerotherapy within the previous 30 days and those whose follow-up was not considered to be feasible were ineligible

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Patients eligible for enrolment were all consecutive patients aged 18 years or over, with a symptomatic ST of the lower limbs at least 5 cm long on compression ultrasonography. Patients who had undergone surgery under general or loco-regional anaesthesia in the previous 10 days, those in whom ST had occurred after sclerotherapy within the previous 30 days and those whose follow-up was not considered to be feasible were ineligible.
Procedure: compression ultrasonography at 3 months
A three-month follow-up prospective study was performed in the subgroup of patients with symptomatic ST but without deep-vein thrombosis on compression ultrasonography or documented symptomatic pulmonary embolism at inclusion, a group defined as patients with 'isolated ST'.
2
Patients eligible for enrolment were all consecutive patients aged 18 years or over, with a symptomatic ST of the lower limbs at least 5 cm long on compression ultrasonography. Patients who had undergone surgery under general or loco-regional anaesthesia in the previous 10 days, those in whom ST had occurred after sclerotherapy within the previous 30 days and those whose follow-up was not considered to be feasible were ineligible.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of confirmed venous thromboembolism at three months.
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall mortality at three months
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Hervé DECOUSUS, Pr, CHU de Saint-Etienne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

January 7, 2009

First Submitted That Met QC Criteria

January 7, 2009

First Posted (Estimate)

January 8, 2009

Study Record Updates

Last Update Posted (Estimate)

January 13, 2009

Last Update Submitted That Met QC Criteria

January 12, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0401080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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