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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01708850
Recruitment Status : Completed
First Posted : October 17, 2012
Last Update Posted : September 8, 2016
Information provided by (Responsible Party):
Gwynivere Davies, London Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Neoplasm Central Venous Catheter Thrombosis Drug: Rivaroxaban Phase 4

Detailed Description:

This will be a prospective cohort study of patients who present with an acute upper limb thrombosis in the setting of a central venous catheter. The total study duration will be 12 weeks, with one follow up telephone visit at 6 months. All patients will be treated with rivaroxaban at a dose of 15 mg orally twice daily for three weeks, followed by 20 mg daily. Anticoagulation will continue for three months regardless of the length of time the catheter is in place. Continuation of anticoagulation beyond this time period is at the discretion of the investigators.

Strengths of this study include its prospective cohort format, and access to a large oncologic population through the London Regional Cancer Program and other corresponding centres. In addition, The Catheter Study looking at CVC survival and safety in patients with cancer diagnosed with UEDVT and treated with a bridging protocol of warfarin/dalteparin was organized primarily through the LHSc and results therein could be directly compared to the results from this study given the similar patient population.

Limitations of this study include the small sample size and the fact that there is no LMWH monotherapy comparison group. In addition, this will be an open study with no blinding, given the nature of line survival. There is also the chance that a proportion of patients will have their catheters removed for other reasons, such as finishing treatment or personal preference, which could affect the validity of survival results.

This design was selected given the small number of patients presenting with this diagnosis each year at our centre, which would present difficulty in accruing enough patients for several comparisons group. Results will be compared to the Catheter Study and previous literature.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study in Cancer Patients With Central Venous Catheter Associated Deep Vein Thrombosis in the Upper Extremity Treated With Rivaroxaban (Catheter 2)
Study Start Date : November 2012
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots
Drug Information available for: Rivaroxaban

Arm Intervention/treatment
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
All specified in arm description. One arm study.
Other Name: Xarelto

Primary Outcome Measures :
  1. Proportion of central line failure, defined as infusion failure that does not respond to 2mg tPA. [ Time Frame: 12 weeks ]
    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.

Secondary Outcome Measures :
  1. Recurrence of DVT or PE [ Time Frame: 12 weeks ]
  2. Major Bleeding [ Time Frame: 12 weeks ]
  3. Clinically Relevant Non-Major Bleeding [ Time Frame: 12 weeks ]
  4. Death [ Time Frame: 12 weeks ]
  5. Time to Central Line Failure [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01708850

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Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A5W9
Sponsors and Collaborators
London Health Sciences Centre
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Principal Investigator: Dr. Michael J. Kovacs, MD, FRCPC London Health Sciences Centre

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Responsible Party: Gwynivere Davies, Resident Researcher (Principal Investigator: Dr. Michael Kovacs, London Health Sciences Centre Identifier: NCT01708850    
Other Study ID Numbers: Catheter 2
First Posted: October 17, 2012    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Upper Extremity Deep Vein Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Venous Thrombosis
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action