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.

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.; ... (2014). 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. Annals of internal medicine, 160(7), pp. 451-7. American College of Physicians 10.7326/M13-2056

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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.

PRIMARY FUNDING SOURCE

None.

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