title: Safety and feasibility of a diagnostic algorithm combining clinical probability, d-dimer testing, and ultrasonography for suspected upper extremity deep venous thrombosis: a prospective management study.
abstract: BACKGROUND
  Although well-established for suspected lower limb deep venous thrombosis, an algorithm combining a clinical decision score, d-dimer testing, and ultrasonography has not been evaluated for suspected upper extremity deep venous thrombosis (UEDVT).
  
  
  OBJECTIVE
  To assess the safety and feasibility of a new diagnostic algorithm in patients with clinically suspected UEDVT.
  
  
  METHODS
  Diagnostic management study. (ClinicalTrials.gov: NCT01324037) SETTING: 16 hospitals in Europe and the United States.
  
  
  METHODS
  406 inpatients and outpatients with suspected UEDVT.
  
  
  METHODS
  The algorithm consisted of the sequential application of a clinical decision score, d-dimer testing, and ultrasonography. Patients were first categorized as likely or unlikely to have UEDVT; in those with an unlikely score and normal d-dimer levels, UEDVT was excluded. All other patients had (repeated) compression ultrasonography. The primary outcome was the 3-month incidence of symptomatic UEDVT and pulmonary embolism in patients with a normal diagnostic work-up.
  
  
  RESULTS
  The algorithm was feasible and completed in 390 of the 406 patients (96%). In 87 patients (21%), an unlikely score combined with normal d-dimer levels excluded UEDVT. Superficial venous thrombosis and UEDVT were diagnosed in 54 (13%) and 103 (25%) patients, respectively. All 249 patients with a normal diagnostic work-up, including those with protocol violations (n = 16), were followed for 3 months. One patient developed UEDVT during follow-up, for an overall failure rate of 0.4% (95% CI, 0.0% to 2.2%).
  
  
  CONCLUSIONS
  This study was not powered to show the safety of the substrategies. d-Dimer testing was done locally.
  
  
  CONCLUSIONS
  The combination of a clinical decision score, d-dimer testing, and ultrasonography can safely and effectively exclude UEDVT. If confirmed by other studies, this algorithm has potential as a standard approach to suspected UEDVT.
  
  
  BACKGROUND
  None.
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mesh_terms: D000465:Algorithms; D003661:Decision Support Techniques; D005240:Feasibility Studies; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis*; D006801:Humans; D011336:Probability; D011446:Prospective Studies; D018615:Ultrasonography, Doppler, Color; D056824:Upper Extremity Deep Vein Thrombosis / Q000175:diagnosis* / Q000000981:diagnostic imaging
chemical_list: D005338:Fibrin Fibrinogen Degradation Products; C036309:fibrin fragment D