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

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.