POST (Prospective Observational Superfial Thrombophlebitis) - Full Text View

Sponsor:	Centre Hospitalier Universitaire de Saint Etienne
Information provided by:	Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:	NCT00818688

Purpose

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.

Condition	Intervention
Thrombophlebitis	Procedure: compression ultrasonography at 3 months

Study Type:	Observational
Study Design:	Cohort, Cross-Sectional
Official Title:	Superficial Thrombophlebitis and Venous Thromboembolism: A Large Prospective Epidemiological Study

Resource links provided by NLM:

MedlinePlus related topics: Deep Vein Thrombosis Pulmonary Embolism Ultrasound

U.S. FDA Resources

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

Primary Outcome Measures:

Incidence of confirmed venous thromboembolism at three months. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Overall mortality at three months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	844
Study Start Date:	March 2005
Study Completion Date:	January 2007
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.

Groups/Cohorts

Assigned Interventions

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.

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.

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 symptomatic ST of the lower limbs.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818688

Locations

France
GUENNEGUEZ
Dieppe, France
BARRELIER
CAEN, France, 34000
CHANUT
Aubenas, France, 07000
GILLET
Bourgoin Jailleu, France, 38000
LEANDRI
ANNONAY, France, 07100

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Investigators

Principal Investigator:

Hervé DECOUSUS, Pr

CHU de SAINT-ETIENNE

More Information

No publications provided

Responsible Party:	CHU de SAINT-ETIENNE ( Pr DECOUSUS Hervé )
Study ID Numbers:	0401080
Study First Received:	January 7, 2009
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00818688 History of Changes
Health Authority:	France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:

Superficial thrombophlebitis (ST)
Deep-vein thrombosis
Symptomatic pulmonary embolism
Symptomatic Superficial Thrombophlebitis of the lower limbs

Additional relevant MeSH terms:

Embolism and Thrombosis
Vasculitis
Peripheral Vascular Diseases
Phlebitis
Vascular Diseases

Cardiovascular Diseases
Venous Thrombosis
Thrombosis
Thrombophlebitis

ClinicalTrials.gov processed this record on November 22, 2009