Study in Cancer Patients With Central Line Associated Clots in the Upper Extremity Treated With Rivaroxaban (Catheter 2)

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with cancer and an upper extremity DVT associated with a central venous catheter (CVC) will receive rivaroxaban. CVC survival will be assessed and compared to previous rates with low molecular weight heparin (LMWH) and warfarin, along with secondary safety outcomes including bleeding and recurrent venous thromboembolism.

The investigators hypothesize that anticoagulation with rivaroxaban in patients with UEDVT secondary to central venous catheters in patients with active malignancy is an effective therapy as quantified by the success of catheter preservation. Prolonged line salvage rate without recurrence of UEDVT will improve the management of cancer patients who develop an upper extremity deep venous thrombosis in the setting of a central venous catheter.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: London Health Sciences Centre
• Treatments: Rivaroxaban

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.