Objective: To summarise the evidence supporting the use of rapid d-dimer testing combined with estimation of clinical probability to exclude the diagnosis of deep venous thrombosis among outpatients.
Data sources: Medline (June 1993 to December 2003), the Database of Abstracts and Reviews (DARE), and reference lists of studies in English.
Selection of studies: We selected 12 studies from among 84 reviewed. The selected studies included more than 5000 patients and used a rapid D-dimer assay and explicit criteria to classify cases as having low, intermediate, or high clinical probability of deep vein thrombosis of the lower extremity among consecutive outpatients.
Review methods: Diagnosis required objective confirmation, and untreated patients had to have at least three months of follow up. The outcome was objectively documented venous thromboembolism. Two authors independently abstracted data by using a data collection form.
Results: When the less sensitive SimpliRED D-dimer assay was used the three month incidence of venous thromboembolism was 0.5% (95% confidence interval 0.07% to 1.1%) among patients with a low clinical probability of deep vein thrombosis and normal D-dimer concentrations. When a highly sensitive D-dimer assay was used, the three month incidence of venous thromboembolism was 0.4% (0.04% to 1.1%) among outpatients with low or moderate clinical probability of deep vein thrombosis and a normal D-dimer concentration.
Conclusions: The combination of low clinical probability for deep vein thrombosis and a normal result from the SimpliRED D-dimer test safely excludes a diagnosis of acute venous thrombosis A normal result from a highly sensitive D-dimer test effectively rules out deep vein thrombosis among patients classified as having either low or moderate clinical probability of deep vein thrombosis.