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

• Published in: Annals of internal medicine Vol. 160; no. 7; p. 451
• Main Authors: Kleinjan, Ankie, Di Nisio, Marcello, Beyer-Westendorf, Jan, Camporese, Giuseppe, Cosmi, Benilde, Ghirarduzzi, Angelo, Kamphuisen, Pieter W, Otten, Hans-Martin, Porreca, Ettore, Aggarwal, Anita, Brodmann, Marianne, Guglielmi, Maria Domenica, Iotti, Matteo, Kaasjager, Karin, Kamvissi, Virginia, Lerede, Teresa, Marschang, Peter, Meijer, Karina, Palareti, Gualtiero, Rickles, Frederick R, Righini, Marc, Rutjes, Anne W S, Tonello, Chiara, Verhamme, Peter, Werth, Sebastian, van Wissen, Sanne, Büller, Harry R
• Format: Journal Article
• Language: English
• Published: United States 01.04.2014
• Subjects: Algorithms; Decision Support Techniques; Feasibility Studies; Fibrin Fibrinogen Degradation Products - analysis; Humans; Probability; Prospective Studies; Ultrasonography, Doppler, Color; Upper Extremity Deep Vein Thrombosis - diagnosis; Upper Extremity Deep Vein Thrombosis - diagnostic imaging
• ISSN: 1539-3704
• DOI: 10.7326/M13-2056

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). To assess the safety and feasibility of a new diagnostic algorithm in patients with clinically suspected UEDVT. Diagnostic management study. (ClinicalTrials.gov: NCT01324037) SETTING: 16 hospitals in Europe and the United States. 406 inpatients and outpatients with suspected UEDVT. 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. 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%). This study was not powered to show the safety of the substrategies. d-Dimer testing was done locally. 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. None.