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Influence of Active awareness about Venous ThromboEmbolism relevance and Rate of Symptomatic deep vein thrombosis
ISRCTN ISRCTN27831914
DOI 10.1186/ISRCTN27831914
ClinicalTrials.gov identifier
EudraCT number
Public title Influence of Active awareness about Venous ThromboEmbolism relevance and Rate of Symptomatic deep vein thrombosis
Scientific title Influence of Active awareness about Venous ThromboEmbolism relevance and Rate of Symptomatic deep vein thrombosis: an observational study
Acronym AVTERS
Serial number at source DIREG L 03049
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.
Lay summary Lay summary under review 2
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
Countries of recruitment Poland
Disease/condition/study domain Deep vein thrombosis (DVT)
Participants - 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
Participants - exclusion criteria 1. Aged under 18
2. No signs or symptoms of deep vein thrombosis
3. No consent for participation in the study
Anticipated start date 01/12/2007
Anticipated end date 30/11/2009
Status of trial Completed
Patient information material Not available in web format, please contact Professor Witold Z. Tomkowski (w.tomkowski@igichp.edu.pl) to request a patient information sheet
Target number of participants 3000
Interventions 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.
Primary outcome measure(s) Evaluation of the impact of an educational campaign dedicated to thromboembolic complications on increased number of correctly diagnosed DVT
Secondary outcome measure(s) 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
Sources of funding Sanofi-Aventis (Poland)
Trial website
Publications
Contact name Prof  Witold  Tomkowski
  Address Instytut Gruzlicy i Chorob Pluc
Plocka Str. 26
  City/town Warsaw
  Zip/Postcode 01-138
  Country Poland
Sponsor Sanofi-Aventis (Poland)
  Address Bonifraterska Str. 17
  City/town Warsaw
  Zip/Postcode 00-203
  Country Poland
  Sponsor website: http://www.sanofi-aventis.pl/
Date applied 12/01/2012
Last edited 31/01/2012
Date ISRCTN assigned 31/01/2012
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