ThRombosis ExclUsion STudy

The study population will be selected from prospective, consecutive ambulatory outpatients
suspected of having venous thromboembolism. Patients will be diagnosed for VTE (PE or DVT)
based on local standard of care. Samples will be collected for future testing with new
D-Dimer assay.

In case of Low/Moderate PTP score and negative VTE diagnosis, patients will be followed for 3
months to evaluate potential development of deep venous thrombosis and/or pulmonary embolism.

Inclusion Criteria:

1. Patient is > 80 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

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.