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Two-Site Compression POINt-OF-CARE Ultrasonography for DVT

Jewish General Hospital · 2017
ClinicalTrials.gov · Datasets · License: Public Domain · 2017
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Introduction Undiagnosed deep vein thrombosis (DVT) can lead to significant morbidity and mortality, including death from DVT-associated massive pulmonary embolism (PE). While several validated clinical prediction rules, blood test and imaging modalities exist to investigate a potential DVT, there is currently a lack of rapid, accessible and reliable methods to exclude the possibility of DVT without resorting to formal venous duplex scanning. Currently, the use in the ED of a validated clinical prediction rule combined with high-sensitivity D-dimer test has a poor predictive value, as 75-90% of patients suspected of DVT have a negative formal venous duplex scan. Compression bedside ultrasound has however recently been shown to be a safe, rapid and accurate method for the diagnosis of proximal DVT in the emergency department with a high sensitivity and specificity (combined sensitivity and specificity of 96.1% and 96.8%, respectively1). Research Question In the present study, the investigators will primarily assess whether two-site compression POCUS combined with a negative age-adjusted D-dimer test can accurately rule out DVT in ED patients regardless of the Wells criteria. Methods This is a single-center, prospective, observational study carried out over one year in the Emergency Department of the Jewish General Hospital in Montreal, Quebec. The investigators aim to enroll a convenience sample of 475 patients aged 18 years and older presenting to the ED with symptoms suggestive of a DVT. All enrolled patients will receive the standard of care required for a lower leg DVT presentation. After calculating Patients DVT risk using modified wells criteria, all patients will undergo POCUS for DVT followed by a D-dimer test. Based on their results, patients will either undergo formal duplex scanning, or will be discharged without further testing and receive a three-month phone follow-up. A true negative lower leg DVT will be defined as follows: 1. Negative follow-
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