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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.
Full description
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 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.
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Inclusion and exclusion criteria
INCLUSION CRITERIA
Patient is < 80 years old.
Patient presenting at least one of these symptoms indicative of proximal DVT or PE:
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:
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
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Data sourced from clinicaltrials.gov
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