POST (Prospective Observational Superfial Thrombophlebitis)

Thrombophlebitis Clinical Trial

— POST  

Official title:

Superficial Thrombophlebitis and Venous Thromboembolism: A Large Prospective Epidemiological Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00818688
• Other study ID #: 0401080
• Status: Completed
• Phase: N/A
• First received: January 7, 2009
• Last updated: January 12, 2009
• Start date: March 2005
• Est. completion date: January 2007

Study information

• Verified date: January 2009
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 844
• Est. completion date: January 2007
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Thrombophlebitis

Intervention

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'.

Locations

Country	Name	City	State
France	LEANDRI	Annonay
France	CHANUT	Aubenas
France	GILLET	Bourgoin Jailleu
France	Barrelier	Caen
France	Guenneguez	Dieppe

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of confirmed venous thromboembolism at three months.		3 months	Yes
Secondary	Overall mortality at three months		3 months	Yes