POST (Prospective Observational Superfial Thrombophlebitis)

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.

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Key information

Conditions

Thrombophlebitis Cardiovascular Diseases Embolism and Thrombosis Peripheral Vascular Diseases Phlebitis Thrombosis Vascular Diseases Vasculitis Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LEANDRI, Annonay, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

compression ultrasonography at 3 months

Procedure

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'.

Primary outcomes

Incidence of confirmed venous thromboembolism at three months.

Time frame: 3 months

Secondary outcomes

Overall mortality at three months

Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Superficial Thrombophlebitis and Venous Thromboembolism: A Large Prospective Epidemiological Study

Acronym: POST

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2007
First posted: Jan 8, 2009
Registry last updated: Jan 13, 2009

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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Completed