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.

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.

PRIMARY FUNDING SOURCE:

None.

• Authors: 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 Rickles, Marc Righini, Anne W S Rutjes, Chiara Tonello, Peter Verhamme, Sebastian Werth, Sanne van Wissen, Harry R Büller
• Journal: Annals of internal medicine (Ann Intern Med) Vol. 160 Issue 7 Pg. 451-7 (Apr 01 2014) ISSN: 1539-3704 [Electronic] United States
• PMID: 24687068 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)

Chemical References

• Fibrin Fibrinogen Degradation Products
• fibrin fragment D

Topics

• Algorithms
• Decision Support Techniques
• Feasibility Studies
• Fibrin Fibrinogen Degradation Products (analysis)
• Humans
• Probability
• Prospective Studies
• Ultrasonography, Doppler, Color
• Upper Extremity Deep Vein Thrombosis (diagnosis, diagnostic imaging)