The purpose of this study is to demonstrate the ability of STA® Liatest® D-Di combined with a clinical pretest probability (PTP) to safely exclude pulmonary embolism (PE) or Deep Venous Thrombosis (DVT) in a 3 month follow-up.
The study population will be selected from prospective, consecutive ambulatory outpatients suspected of having venous thromboembolism. These patients will first be evaluated using the Wells score: * patients with low or moderate pretest probability will be considered for D-dimer testing, those with D-dimer positive will be considered for an imaging procedure, * patients with high pretest probability will be considered for an imaging procedure. Patients with "low or moderate" pretest probability and a negative D-Dimer result will be followed for 3 months to evaluate potential development of deep venous thrombosis and/or pulmonary embolism. These patients will be contacted by phone 3 month after their first visit.
Study Type
OBSERVATIONAL
Enrollment
2,040
Northwestern Medical Center
Chicago, Illinois, United States
Indiana University Health
Indianapolis, Indiana, United States
To demonstrate the ability of STA Liatest DDi combined with a clinical pretest probability (PTP) to safely exclude pulmonary embolism or deep venous thrombosis in a 3 month follow-up
Occurence of pulmonary embolism or deep venous thrombosis during the 3 month follow-up after negative diagnosis (i.e. patients with PTP low/moderate and negative STA Liatest D-Di test)
Time frame: at 3 months
1. To analyse results homogeneity (inter-centers) in the group "positive D-dimer result and negative diagnosis" (descriptive statistics only). 2. To determine prevalence of VTE in PTP high patients based on imaging results
1\. Prevalence of VTE in PTP high patients based on imaging results.
Time frame: at 3 months
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