Background: When deep venous thrombosis is suspected, objective testing is required to confirm or refute the diagnosis.
Objective: To determine whether the combination of a low clinical suspicion and a normal d-dimer result rules out deep venous thrombosis.
Design: Prospective cohort study.
Setting: Three tertiary care hospitals in Canada.
Patients: 445 outpatients with a suspected first episode of deep venous thrombosis.
Interventions: Patients were categorized as having low, moderate, or high pretest probability of thrombosis and underwent whole-blood d-dimer testing. Patients with a low pretest probability and a negative result on the d-dimer test had no further diagnostic testing and received no anticoagulant therapy. Additional diagnostic testing was done in all other patients.
Measurements: Venous thromboembolic events during 3-month follow-up.
Results: 177 (40%) patients had both a low pretest probability and a negative d-dimer result. One of these patients had deep venous thrombosis during follow-up (negative predictive value, 99.4% [95% CI, 96.9% to 100%]).
Conclusion: The combination of a low pretest probability of deep venous thrombosis and a negative result on a whole-blood d-dimer test rules out deep venous thrombosis in a large proportion of symptomatic outpatients.