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QUESTION: Can a d-dimer assay, alone or combined with structured clinical risk assessment, be used to rule out deep venous thrombosis (DVT) in symptomatic patients?
Design
A blinded comparison of d-dimer test results plus results from a structured clinical assessment with duplex ultrasonographic scanning (DUS).
Setting
A university hospital in Basel, Switzerland.
Participants
360 consecutive patients were screened, and 343 participants, who had complete information (median age 61 y, age range 17 to 94 y, 61% women, 52% inpatients, 398 limbs), were investigated for suspected DVT. No exclusion criteria were specified.
Description of tests and diagnostic standard
A d-dimer analysis was done (SimpliRED, Agen Biomedical, Brisbane, Australia) initially. Patients were then divided into groups at low or high risk for DVT based on a previously validated clinical risk assessment score* calculated by using data on the presence of cancer, immobilisation, recent surgery, localised tenderness, swelling, pitting edema, and collateral superficial veins. Data were compiled by an examiner who was blinded to the d-dimer test results. DUS (diagnostic standard) was done in a blinded fashion to identify all (proximal and calf) DVT. All scans were conclusive.
Main outcome measures
Sensitivity and specificity for the diagnosis of DVT for patients and limbs using d-dimer test results alone and combined with a clinical risk assessment.
Main results
Of the 343 patients, 71% were at low risk for …
Footnotes
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Source of funding: none stated.
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For correspondence: Dr KA Jaeger, Department of Angiology, University Hospital, University of Basel, Petersgraben 4, CH-4031 Basel, Switzerland. Fax +41 61 265 5356.
↵* Wells PS, Anderson DR, Bormanis J, et al. Lancet 1997;350:1795–8.