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

NCT01708850 | Completed Phase 4

• 1 other identifier: Catheter 2
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neoplasm; Central Venous Catheter Thrombosis

Outcome Measures

Primary Outcomes (1)

• Proportion of central line failure, defined as infusion failure that does not respond to 2mg tPA.

  The primary endpoint of the study will be proportion of central line failure, defined as infusion failure that does not respond to 2mg tPA, within the 3 months of study follow-up.

  12 weeks

Secondary Outcomes (5)

• Recurrence of DVT or PE

  12 weeks

• Major Bleeding

  12 weeks

• Clinically Relevant Non-Major Bleeding

  12 weeks

• Death

  12 weeks

• Time to Central Line Failure

  12 weeks

Study Arms (1)

Rivaroxaban

OTHER

Rivaroxaban 15 mg po bid x 3 weeks, followed by rivaroxaban 20 mg po daily x 9 weeks. Then up to discretion of investigator to decide regarding further anticoagulation as study length is limited to 12 weeks.

Drug: Rivaroxaban

Interventions

Rivaroxaban DRUG

All specified in arm description. One arm study.

Also known as: Xarelto

Rivaroxaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female \> 18 years of age.
• 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.
• 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.
• Willing to provide written informed consent.

You may not qualify if:

• Dialysis catheters.
• Active bleeding or high risk for major bleeding.
• Platelet Count \< 75 x 109/L.
• Creatinine Clearance \< 30 mL/min.
• Currently on other anticoagulant with therapeutic intent for another indication.\*
• Pulmonary embolism accompanied by hemodynamic instability or oxygen requirement.
• Inability to infuse through the catheter after a trial of intraluminal thrombolytic therapy (ie. 2 mg tPA).
• Patients with AML, ALL or multiple myeloma with a bone marrow or stem cell transplant planned within the next 3 months.
• Thrombosis involving the brachial or cephalic veins only.
• Treatment for current episode \> 7 days with any acceptable anticoagulant therapy.
• Concomitant use of P-glycoprotein and CYP3A4 inhibitors (ie. azole antifungals such as ketoconazole) or inducers (ie. rifampicin, antiepileptics).\*
• Recent coronary artery stent requiring dual anti-platelet therapy.

Sponsors & Collaborators

• London Health Sciences Centre: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5W9, Canada

Location

Related Publications (1)

• Kovacs MJ, Kahn SR, Rodger M, Anderson DR, Andreou R, Mangel JE, Morrow B, Clement AM, Wells PS. A pilot study of central venous catheter survival in cancer patients using low-molecular-weight heparin (dalteparin) and warfarin without catheter removal for the treatment of upper extremity deep vein thrombosis (The Catheter Study). J Thromb Haemost. 2007 Aug;5(8):1650-3. doi: 10.1111/j.1538-7836.2007.02613.x. Epub 2007 May 7.

  PMID: 17488349 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Upper Extremity Deep Vein Thrombosis

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dr. Michael J. Kovacs, MD, FRCPC

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Researcher (Principal Investigator: Dr. Michael Kovacs

Study Record Dates

• First Submitted: October 15, 2012
• First Posted: October 17, 2012
• Study Start: November 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 8, 2016

Record last verified: 2016-09

Locations

CA (1)