Prevention of Thromboembolic Events – European Registry in Venous Thromboembolism
- Conditions
- MedDRA - Venous ThromboembolismI82Other venous embolism and thrombosis
- Registration Number
- DRKS00004795
- Lead Sponsor
- Daiichi-Sankyo Europe GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 3544
Inclusion Criteria
• Established acute initial or recurrent VTE
• In hospitals, surgical or non-surgical wards or specialised office-based centres
• Written informed consent for participation in the registry (including telephone follow-ups)
• Not simultaneously participating in a double blind interventional study
Exclusion Criteria
No explicit medical exclusion criteria are stated
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to assess the 12 month direct healthcare resource use and estimated costs following acute first time (initial) or recurrent venous thromboembolism. In addition, detailed insight on the characteristics and management of patients with acute venous thromboembolism (in particular deep vein thrombosis and/or pulmonary embolism) with focus on prevention of related events (e. g. bleeding or other complications, recurrence of deep vein tmbosis/pulmonary embolism, myocardial infarction, stroke, systemic embolic event, post thrombotic syndrome, percutaneous coronary intervention, coronary artery bypass graft, and death) will be collected.
- Secondary Outcome Measures
Name Time Method - To describe the treatment satisfaction (PACT Q2), health related quality of life (EQ 5D), and clinical outcomes following first time (initial) or recurrent venous thromboembolism. Timepoints: Baseline, 1, 3, 6 and 12 month(s) after baseline<br>- To explore relationship between anticoagulants and duration of therapy and resource use, estimated costs, treatment satisfaction (PACT Q), and health related quality of life (EQ D5), and clinical outcomes.<br>- To explore geographic variations in the management of patients with venous thromboembolism<br>