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- 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.
- 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
- Abstract
<bold>Background: </bold>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).<bold>Objective: </bold>To assess the safety and feasibility of a new diagnostic algorithm in patients with clinically suspected UEDVT.<bold>Design: </bold>Diagnostic management study. (ClinicalTrials.gov: NCT01324037) SETTING: 16 hospitals in Europe and the United States.<bold>Patients: </bold>406 inpatients and outpatients with suspected UEDVT.<bold>Measurements: </bold>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.<bold>Results: </bold>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%).<bold>Limitations: </bold>This study was not powered to show the safety of the substrategies. d-Dimer testing was done locally.<bold>Conclusion: </bold>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.<bold>Primary Funding Source: </bold>None.
- Publication
Annals of Internal Medicine, 2014, Vol 160, Issue 7, p451
- ISSN
0003-4819
- Publication type
journal article
- DOI
10.7326/M13-2056