Multi-Detector Spiral Computed Tomography Alone Versus Combined Strategy With Lower Limb Compression Ultrasonography in Outpatients Suspected of Pulmonary Embolism
The main hypothesis for this study is that the diagnostic approach of pulmonary embolism (PE) by evaluation of clinical probability, D-dimer test dosage and multi-detector helical computed tomography (hCT) is as safe as the classical "approach" using clinical probability, D-dimer test, lower limb compression ultrasonography and multi-detector helical computed tomography.
The second hypothesis involves evaluating the role of searching distal, i.e. infrapopliteal, deep venous thromboses (DVTs) in the diagnostic approach of pulmonary embolism.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
|Official Title:||Multi-Detector Spiral Computed Tomography Alone Versus Combined Strategy With Lower Limb Compression Ultrasonography in Outpatients Suspected of Pulmonary Embolism: A Randomised Non-Inferiority Trial [CTEP4]|
- The primary outcome variable will be the number of thromboembolic events in the 3-month follow-up period in each group.
- Costs incurred in each study arm. (Costs will be directly measured and will represent direct costs, not charges. Measurements will include all costs due to diagnosis of PE, including the costs associated with the length of stay in the emergency ward)
- Classification performances of the revised Geneva standardised clinical score, as assessed by its capacity to distinguish patients having low, intermediate and high probability of PE
- Proportion of patients in whom hCT could have been avoided by using the presence of a distal DVT to rule in the diagnosis of PE (proportion of patients with both distal DVT on ultrasonography and PE on multi-detector hCT)
- Proportion of patients with distal DVT on ultrasonography but without pulmonary embolism on multi-detector hCT and without thromboembolic event during the 3 months follow-up
|Study Start Date:||January 2005|
|Estimated Study Completion Date:||October 2006|