Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-24 @ 5:18 PM
NCT ID:
NCT01708850
Eligibility Criteria:
Inclusion Criteria:
1. Male or female \> 18 years of age.
2. Symptomatic acute upper limb thrombosis in the axillary, subclavian, innominate or internal jugular veins, with or without pulmonary embolism, associated with central venous catheter objectively documented by compression ultrasonography, venogram or CT scan.
3. Diagnosis of active malignancy (other than non-melanoma skin cancer), defined as 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. 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 (ie. 2 mg tPA).
8. Patients with AML, ALL or multiple myeloma with a bone marrow or stem cell transplant planned within the next 3 months.
9. Thrombosis involving the brachial or cephalic veins only.
10. Treatment for current episode \> 7 days with any acceptable anticoagulant therapy.
11. Concomitant use of P-glycoprotein and CYP3A4 inhibitors (ie. azole antifungals such as ketoconazole) or inducers (ie. rifampicin, antiepileptics).\*
12. Recent coronary artery stent requiring dual anti-platelet therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01708850
Study Brief:
Protocol Section:
NCT01708850