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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by London Health Sciences Centre.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Gwynivere Davies, London Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01708850
First received: October 15, 2012
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Neoplasm
Central Venous Catheter Thrombosis
Drug: Rivaroxaban
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by London Health Sciences Centre:

Primary Outcome Measures:
  • Proportion of central line failure, defined as infusion failure that does not respond to 2mg tPA. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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:
  • Recurrence of DVT or PE [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Major Bleeding [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Clinically Relevant Non-Major Bleeding [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Time to Central Line Failure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: November 2012
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Rivaroxaban
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708850

Contacts
Contact: Roweena Corpuz 519-685-8500 ext 55299 roweena.corpuz@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Centre Not yet recruiting
London, Ontario, Canada, N6A5W9
Principal Investigator: Dr. Michael J. Kovacs, MD, FRCPC         
Sub-Investigator: Dr. Martha Louzada, MD, FRCPC         
Sub-Investigator: Dr. Gwynivere A Davies, MD         
Sub-Investigator: Dr. Alejandro Lazo-Langner, MD, FRCPC         
Sponsors and Collaborators
London Health Sciences Centre
Investigators
Principal Investigator: Dr. Michael J. Kovacs, MD, FRCPC London Health Sciences Centre
  More Information

Publications:
Responsible Party: Gwynivere Davies, Resident Researcher (Principal Investigator: Dr. Michael Kovacs, London Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01708850     History of Changes
Other Study ID Numbers: Catheter 2
Study First Received: October 15, 2012
Last Updated: October 16, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Thrombosis
Upper Extremity Deep Vein Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases
Venous Thrombosis
Rivaroxaban
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014