Clinical Trial:

Venous Thromboembolism Study

Full Name

Deep Vein Thrombosis: STA® -Liatest® D-Di  Exclusion of Venous Thromboembolism (VTE) (1_PRO00001084)

Description

Patients presenting to the emergency department with at least one symptom suggestive of proximal deep vein thrombosis (DVT) or pulmonary embolism (PE) will be invited to participate. Symptoms for proximal DVT are leg pain, tenderness (discomfort through palpation), leg swelling, and/or edema. Symptoms for PE are coughing up blood (hemoptysis), lung related chest pain, and shortness of breath (dyspnea). Participants will be evaluated using the Wells Score. Participants with low or moderate pre-test probability (PTP) of venous thromboembolism (VTE) are considered for D-dimer testing. Those with a positive D-dimer result will be considered for an imaging procedure. Standard of care imaging studies will be ordered as determined by the attending physician. Participants with low or moderate pre-test probability and a negative D-dimer result will be followed for 3 months to evaluate potential development of DVT and/or PE. Those participants will be contacted by telephone. Information regarding the development of DVT and/or PE in the period between 90 and 120 days after their enrollment visit will be collected. The results of the STA® - Liatest® D-Di assay will only be collected for suspected VTE participants with low or moderate pre-test probability. In addition, participants will be asked to donate any leftover blood to establish a plasma bank, which is optional.

Eligibility

Inclusion Criteria
  • Must be less than 80 years old
  • Must be willing to comply with specified follow-up evaluation at 3 months and can be contacted by telephone
  • Must present with at least one symptom for proximal deep vein thrombosis (DVT) (leg pain, tenderness, leg swelling, and/or edema) or pulmonary embolism (PE) (lung related chest pain, shortness of breath (dyspnea), or coughing up blood (hemoptysis)
Doctor(s) Running This Study