Extended Versus Rapid Analysis of the Leg Vein System: a Multicenter Ultrasound Study (The ERASMUS Study) – An Interim Analysis

The reliability of diagnostic strategies based on compression ultrasonography (CUS) for the diagnosis of proximal deep venous thrombosis (DVT) in symptomatic (out)patients is well documented; however these approaches never gained widespread application.Echo-color-Doppler (ECD), is regularly adopted by vascular laboratories as first line test in case of clinically suspected DVT, although the specificity of calf veins imaging is uncertain, as is the negative predictive value of a normal ECD workup. To date, no direct comparison of these strategies is available in the literature. We designed a randomised prospective study to compare the safety and feasibility of two diagnostic approaches: a "rapid" (CUS + D-dimer), and an "extended" strategy (ECD of the whole-leg). All consecutive patients with suspected symptomatic DVT of the legs, if at their first episode, and if not meeting exclusion criteria, will be enrolled in the study. The primary outcome of the study will be the rate of symptomatic VTE during a 3-month follow-up, after a normal diagnostic workup with either of the two proposed strategies. All events will be adjudicated by a blind and independent committee, based on the results of objective testing. An interim data analysis will be presented during the congress session.