STA®-Liatest®D-Di-Exclusion of Venous Thromboembolism

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.

Inclusion criteria

• Patient is < 80 years old.
• Patient presenting at least one of these symptoms indicative of proximal DVT or PE:

• symptoms for proximal DVT: leg pain, tenderness (discomfort through palpation), leg swelling, and /or edema,
• symptoms for PE: hemoptysis, lung related chest pain, dyspnea.
• Patient provides written informed consent to participate in the study (or verbal no-opposition, as allowed by local regulations)
• Patient is willing to comply with specified follow-up evaluation at 3 months and can be contacted by telephone

Exclusion criteria

• Patient presenting with a condition that may be associated with increased D-dimer levels, even in the absence of VTE, such as:

• Fibrinolytic therapy within the previous seven (7) days,
• Bone fracture or surgery (with general anesthesia longer than thirty (30) minutes) within the previous one (1) month,
• Deep hematoma diagnosed by imaging techniques within the previous one (1) month,
• Disseminated malignancies and active cancer (active cancer defined as: cancer for which therapeutic or palliative treatment is either ongoing at the time of enrolment or has stopped less than six (6) months before enrolment),
• Sepsis, severe infections, pneumonia within the previous 1 month,
• Known liver cirrhosis,
• Pregnancy or post-partum within the previous 1 month,
• Atherosclerotic vascular disease thrombosis within the previous 1month (e.g. myocardial infarction, stroke, coronary syndrome, peripheral artery disease stage III or IV),
• Sickle cell disease,
• Patients presenting with a suspect thrombotic event related to catheter implantation
• Ongoing therapeutic anticoagulants (curative and preventive treatment) starting twenty four (24) hours or more before the D-dimer is measured
• Previous anticoagulant therapy stopped less than three (3) months before the D-dimer is measured
• Patients with previous DVT/PE occurred less than three (3) months from screening.
• Suspect thrombotic events in other locations at screening, including distal to the knee and upper extremity DVT (based on standard of care examinations)
• Patients with known tissue plasminogen activator (tPA) deficiency
• Patient participating or who has participated within one month of enrollment in another investigational study
• Major co-morbid condition(s) or other reasons that could limit the patient's ability to participate in the study or to comply with follow-up requirements, or impact the scientific integrity of the study