N/A
N=8,256
Epidemiology of Thromboembolism Disease: A Cohort Study
Vascular Diseases · Embolism and Thrombosis · Phlebitis · Venous Insufficiency · Pulmonary Embolism
Bottom Line
View on ClinicalTrials.gov: NCT00670540 ↗Enrolled (actual)
8,256
Serious AEs
23.3%
Results posted
May 2012
Primary outcome: Primary: Percentage of Participants Who Developed a New or Recurrence of Venous Thromboembolism (VTE) — 8.94 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- procedure of Deep Vein Thrombosis (DVT) and PE (Pulmonary Embolism) diagnosis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospital, Grenoble
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Developed a New or Recurrence of Venous Thromboembolism (VTE) |
8.94 | — |
| SECONDARY Percentage of Participants Who Developed Major Bleeding Events |
3.00 | — |
| SECONDARY Percentage of Participants With Treatment Anticoagulant Prescribed |
52.23 | — |
| SECONDARY Percentage of Participants Who Developed Cardiovascular Events |
6.98 | — |
| SECONDARY Percentage of Participants Who Died From Any Cause |
17.0 | — |
| SECONDARY Percentage of Participants Who Developed Cancer Onset |
4.10 | — |
| SECONDARY Percentage of Participants Who Developed Venous Insufficiency (Leg Ulcer) |
0.34 | — |
Summary
The purpose of this study is to determine different risk factors of thromboembolic disease. Different points will be studied
1. do different types of thromboembolic disease (distal Deep Vein Thrombosis (DVT), proximal DVT, Pulmonary Embolism (PE) and DVT, PE without DVT) have the same clinical significance (risk factors and prognosis) ?
2. Is it necessary to obtain a detailed history of thromboembolic disease ?
3. Do older patients have particular risk factors ?
4. Do preventive treatments modify the level of risk factors and the clinical signs of thromboembolic disease ?
5. Do predictive clinical scores have the same performance for both in and outpatients ?
6. Can patients with a potential high level of thromboembolic risk (surgery, pregnancy) but no clinical thromboembolic symptoms, develop a low risk ?
7. The evolution of the disease in patients with negative or positive Venous ThromboEmbolism (VTE) exploratory tests.
Eligibility Criteria
Inclusion Criteria
- patient aged more than 18
- male or female
- patients with clinical thromboembolic signs (deep vein thrombosis or pulmonary embolism)
Exclusion Criteria
- patient less than 18 years old
- patient unable to understand
- patient who refused to participate
Data sourced from ClinicalTrials.gov (NCT00670540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.