Plain English Summary

Lay summary under review 2

Trial website

Contact information

Type

Scientific

Primary contact

Prof Witold Tomkowski

ORCID ID

Contact details

Instytut Gruzlicy i Chorob Pluc
Plocka Str. 26
Warsaw
01-138
Poland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DIREG L 03049

Study information

Scientific title

Influence of Active awareness about Venous ThromboEmbolism relevance and Rate of Symptomatic deep vein thrombosis: an observational study

Acronym

AVTERS

Study hypothesis

An increase in public awareness would result in an increase in the frequency of objectively confirmed deep vein thrombosis (DVT), wherever its anatomic location.

Ethics approval

Bioethics Committee, National TB and Lung Diseases Research Institute, Warsaw, Poland, 19 November 2007, ref: KE-142/2007

Study design

Multicenter observational study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

GP practices

Trial type

Screening

Patient information sheet

Not available in web format, please contact Professor Witold Z. Tomkowski (w.tomkowski@igichp.edu.pl) to request a patient information sheet

Condition

Deep vein thrombosis (DVT)

Intervention

A campaign to raise public awareness of DVT was conducted in an urban population cluster (A) of approximately 100,000 via distribution of brochures four times during a year and publishing posters and newsletter articles.

A comparison urban population cluster (B) of approximately 1,574,000, was not exposed to this campaign.

Patients symptomatic for DVT in both populations were referred by general practitioners for a standardized compression ultrasound (CUS) of the whole leg at no charge to the patient. Reports of positive CUS exams documented by photographs were analyzed by an independent adjudication committee blinded to the population cluster. Cluster A was followed for 8 months after the information campaign ended.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Evaluation of the impact of an educational campaign dedicated to thromboembolic complications on increased number of correctly diagnosed DVT

Secondary outcome measures

1. Evaluation of the rate of correctly diagnosed DVT among the general population in Poland
2. Evaluation of the risk factors in patients with confirmed DVT
3. Evaluation of which diagnostic methods are applied to confirm DVT symptoms

Overall trial start date

01/12/2007

Overall trial end date

30/11/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female aged > 18
2. A patient with clinical symptoms suggesting thrombosis, referred by primary care physicians selected to the study
3. A patient with deep vein thrombosis confirmed with diagnostic methods
4. A patient with newly diagnosed deep vein thrombosis or with recurring thrombosis in a vein with existing thrombosis process

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

3000

Participant exclusion criteria

1. Aged under 18
2. No signs or symptoms of deep vein thrombosis
3. No consent for participation in the study

Recruitment start date

01/12/2007

Recruitment end date

30/11/2009

Locations

Countries of recruitment

Poland

Trial participating centre

Instytut Gruzlicy i Chorob Pluc
Warsaw
01-138
Poland

Sponsor information

Organisation

Sanofi-Aventis (Poland)

Sponsor details

Bonifraterska Str. 17
Warsaw
00-203
Poland

Sponsor type

Industry

Website

http://www.sanofi-aventis.pl/

Funders

Funder type

Industry

Funder name

Sanofi-Aventis (Poland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Editorial Notes