Safety and feasibility of a diagnostic algorithm combining clinical probability, D-dimer test and ultrasonography in suspected upper extremity deep vein thrombosis

Background: Ultrasonography is currently used as the reference test for clinically suspected upper extremity deep vein thrombosis (UEDVT) although the diagnostic accuracy of the test for this indication remains less well established compared to DVT of the legs. The safety of withholding anticoagulant therapy without additional testing in patients with suspected UEDVT who have an unlikely clinical probability score and a normal D-dimer test has not been evaluated. Moreover, no study has so far evaluated the safety and feasibility of (serial) ultrasonography in patients with either a likely clinical decision rule or abnormal D-dimer. Aim: Aim of this study is to assess the safety and feasibility of a diagnostic algorithm that combines a clinical score, D-dimer test, and compression ultrasonography as a diagnostic work-up for UEDVT. Design: This is a prospective multicenter management study. Patients: All patients with suspected UEDVT, including patients with central venous catheters for chemotherapy, will be included in this study. Patients with suspected UEDVT will be handled according to the attached flow-chart. All patients will be followed for 3 months. The primary outcome will be the cumulative 3-month incidence of objectively confirmed symptomatic venous thromboembolic events. Based on a maximum failure rate of the diagnostic work-up of 3%, 400 patients will be needed to test the safety of the diagnostic strategy. Organization: We aim for an inclusion rate of 20 patients per center per year; with an inclusion period of 1.5 years and to compensate for inactive centers, we will need approximately 20 centers. A steering committee will be formed and outcomes will be adjudicated by a central adjudication committee. An electronic case report form will be used for data collection. (Graph presented)