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

Authors

Ankie Kleinjan, Amsterdam UMC - University of Amsterdam
Marcello Di Nisio, University of G. d'Annunzio Chieti and Pescara
Jan Beyer-Westendorf, Dresden University Faculty of Medicine and University Hospital Carl Gustav Carus
Giuseppe Camporese, Azienda Ospedaliera Di Padova
Benilde Cosmi, Alma Mater Studiorum Università di Bologna
Angelo Ghirarduzzi, Instituto di Ricovero e Cura A Carattere Scientifico
Pieter W. Kamphuisen, University of Groningen, University Medical Center Groningen
Hans Martin Otten, Slotervaart Hospital
Ettore Porreca, University of G. d'Annunzio Chieti and Pescara
Anita Aggarwal, Washington DC VA Medical Center
Marianne Brodmann, Medizinische Universität Graz
Maria Domenica Guglielmi, University of G. d'Annunzio Chieti and Pescara
Matteo Iotti, Instituto di Ricovero e Cura A Carattere Scientifico
Karin Kaasjager, University Medical Center Utrecht
Virginia Kamvissi, Dresden University Faculty of Medicine and University Hospital Carl Gustav Carus
Teresa Lerede, Papa Giovanni XXIII Hospital
Peter Marschang, Medizinische Universitat Innsbruck
Karina Meijer, University of Groningen, University Medical Center Groningen
Gualtiero Palareti, Alma Mater Studiorum Università di Bologna
Frederick R. Rickles, Washington DC VA Medical Center
Marc Righini, Hôpitaux universitaires de Genève
Anne W.S. Rutjes, Institut fur Sozial- und Praventivmedizin
Chiara Tonello, Azienda Ospedaliera Di Padova
Peter Verhamme, KU Leuven– University Hospital Leuven
Sebastian Werth, Dresden University Faculty of Medicine and University Hospital Carl Gustav Carus
Sanne Van Wissen, Our Lady Hospital - Amsterdam
Harry R. Büller, Amsterdam UMC - University of Amsterdam

Document Type

Journal Article

Publication Date

4-1-2014

Journal

Annals of Internal Medicine

Volume

160

Issue

7

DOI

10.7326/M13-2056

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. Design: Diagnostic management study. (ClinicalTrials.gov: NCT01324037) Setting: 16 hospitals in Europe and the United States. Patients: 406 inpatients and outpatients with suspected UEDVT. Measurements: 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%). Limitations: This study was not powered to show the safety of the substrategies. D-Dimer testing was done locally. Conclusion: 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. © 2014 American College of Physicians.

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