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

Ankie Kleinjan*, Marcello Di Nisio, Jan Beyer-Westendorf, Giuseppe Camporese, Benilde Cosmi, Angelo Ghirarduzzi, Pieter W. Kamphuisen, Hans-Martin Otten, Ettore Porreca, Anita Aggarwal, Marianne Brodmann, Maria Domenica Guglielmi, Matteo Iotti, Karin Kaasjager, Virginia Kamvissi, Teresa Lerede, Peter Marschang, Karina Meijer, Gualtiero Palareti, Frederick R. RicklesMarc Righini, Anne W.S. Rutjes, Chiara Tonello, Peter Verhamme, Sebastian Werth, Sanne Van Wissen, Harry R. Büller

*Bijbehorende auteur voor dit werk

OnderzoeksoutputAcademicpeer review

50 Citaten (Scopus)

Samenvatting

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.

Originele taal-2English
Pagina's (van-tot)451-457
Aantal pagina's7
TijdschriftAnnals of Internal Medicine
Volume160
Nummer van het tijdschrift7
DOI's
StatusPublished - 1-apr-2014

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