Research & Innovation

TRUST

Clinical Trials

SLUHN 2016-76

ThRombosis exclUsion STudy for STA® - Liatest® D-Di XL

Physician & Study Coordinator

Study Coordinator

Susan Hahn
484-526-7825

susan.hahn2@sluhn.org

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Synopsis

Synopsis: This is a research study investigating the diagnostic utility of a new laboratory test (called STA® - Liatest® D-Di XL) in ruling out the presence of a blood clot, or venous thromboembolism (VTE).  A VTE is a blood clot in the deep veins and we hope to learn more about the tests for DVT and PE, blood clots in the legs and lungs from your participation in this study.

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Inclusion Criteria
  1. Patient is > 18 years old.
  2. Patient presents 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.
  3. Patient provides written informed consent to participate in the study
  4. Patient is willing to comply with specified follow-up evaluation at 3 months and can be contacted by telephone

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Exclusion Criteria
  1. 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,
    • Disseminated intravascular coagulation
    • 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 having delivered 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,
  2. Patients presenting with a suspect thrombotic event related to catheter implantation
  3. Ongoing therapeutic anticoagulants (curative and preventive regimen) started twenty four (24) hours or more before blood draw (except aspirin and platelet inhibitors)
  4. Previous anticoagulant therapy stopped less than three (3) months before blood draw (except aspirin and platelet inhibitors)
  5. Patients with previous DVT/PE occurred less than three (3) months from screening.
  6. Suspect thrombotic events in other locations at screening, including distal to the knee and upper extremity DVT (based on standard of care examinations)
  7. Patients with known tissue plasminogen activator (tPA) deficiency
  8. Patient participating or who has participated within one month of enrolment in another investigational study
  9. Major co-morbid condition(s) or other reasons that could limit the patients 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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