Treatments and/or Procedures

Study Criteria

Inclusion Criteria:

  1. Male or female > 18 years of age.

  2. Symptomatic acute upper limb thrombosis in the axillary, subclavian or internal
     jugular veins, with or without pulmonary embolism, associated with central venous
     catheter objectively documented by compression ultrasonography, venogram or
     Computerized Tomography (CT) scan.

  3. Diagnosis of active malignancy, as defined by patients who are either receiving active
     treatment, or have metastatic disease or who have been diagnosed within the past two
     years.

  4. Willing to provide written informed consent.

Exclusion Criteria:

  1. Presence of dialysis catheters

  2. Active bleeding or high risk for major bleeding

  3. Platelet Count < 75 x 109/L

  4. Creatinine Clearance < 30 mL/min

  5. Currently on other anticoagulant with therapeutic intent for another indication

  6. Pulmonary embolism accompanied by hemodynamic instability or oxygen requirement

  7. Inability to infuse through the catheter after a trial of intraluminal thrombolytic
     therapy (2 mg tPA).

  8. Patients with Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL) or
     multiple myeloma with a bone marrow or stem cell transplant planned within the next 3
     months

  9. Treatment for current episode > 7 days with any acceptable anticoagulant therapy

 10. Concomitant use of p-glucoprotein and Cytochrome P450 3A4 (CYP3A4) inhibitors (for
     example azole antifungals such as ketoconazole) or inducers (for example rifampicin,
     antiepileptics)

 11. Recent coronary artery stent requiring dual anti-platelet therapy (for example
     acetylsalicylic acid [ASA] and Plavix)

 12. If female of childbearing potential: pregnancy and/or breastfeeding