NCT00818688

POST (Prospective Observational Superfial Thrombophlebitis)

Superficial Thrombophlebitis and Venous Thromboembolism: A Large Prospective Epidemiological Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 844 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Thrombophlebitis

Interventions

Type	Name	Description
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'.

Timeline

• Start date: 2005-03-01
• Primary completion: 2006-10-01
• Completion: 2007-01-01
• First posted: 2009-01-08
• Last updated: 2009-01-13

Locations

5 sites across 1 country: France