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Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) in Cancer Patients

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ClinicalTrials.gov Identifier: NCT03100071
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : February 28, 2019
Sponsor:
Collaborators:
Ottawa Hospital Research Institute
Jewish General Hospital
Information provided by (Responsible Party):
Michael Kovacs, Lawson Health Research Institute

Brief Summary:
Cancer patients with Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) will be treated with Low Molecular Weight Heparin (LMWH) and apixaban. Study duration is 12 weeks.

Condition or disease Intervention/treatment
Cancer Patients Central Venous Catheter Thrombosis Upper Extremity Thrombosis Drug: Apixaban

Detailed Description:
Cancer patients who have developed blood clot in the arm that has the central venous catheter will be treated with standard of care blood thinning injection of low molecular weight heparin for 1 week and then for apixaban 5 mg twice daily for the rest of 11 weeks. Data will be collected to see if the central venous catheter "survived" or remained in place and did not have to be taken out because of the clot.

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study in Cancer Patients With Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) in the Upper Extremity Treated With Low Molecular Weight Heparin (LMWH) and Apixaban (Catheter 3)
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban


Intervention Details:
  • Drug: Apixaban
    Patients will be treated with Low Molecular Weight Heparin (LMWH) for 1 week and then with apixaban 5 milligram (mg) twice daily for 11 weeks.
    Other Name: Eliquis


Primary Outcome Measures :
  1. Central Line Failure [ Time Frame: within 3 months of study follow-up ]
    Infusion failure that does not respond to 2 milligram (mg) tissue Plasminogen Activator (tPA)


Secondary Outcome Measures :
  1. Recurrent Venous Thromboembolism (VTE) [ Time Frame: within 3 months of study follow-up ]
    recurrence of blood clot either in leg or lung or both

  2. Bleeding [ Time Frame: within 3 months of study follow-up ]
    Major bleeding, clinically relevant minor bleed, death, time to central line failure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Cancer patients with central venous catheter associated deep vein thrombosis in the upper extremity
Criteria

Inclusion Criteria:

  1. Male or female > 18 years of age.
  2. Symptomatic acute upper limb thrombosis in the axillary, subclavian or internal jugular veins, with or without pulmonary embolism, associated with central venous catheter objectively documented by compression ultrasonography, venogram or Computerized Tomography (CT) scan.
  3. Diagnosis of active malignancy, as defined by 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. Presence of 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 (2 mg tPA).
  8. Patients with Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL) or multiple myeloma with a bone marrow or stem cell transplant planned within the next 3 months
  9. Treatment for current episode > 7 days with any acceptable anticoagulant therapy
  10. Concomitant use of p-glucoprotein and Cytochrome P450 3A4 (CYP3A4) inhibitors (for example azole antifungals such as ketoconazole) or inducers (for example rifampicin, antiepileptics)
  11. Recent coronary artery stent requiring dual anti-platelet therapy (for example acetylsalicylic acid [ASA] and Plavix)
  12. If female of childbearing potential: pregnancy and/or breastfeeding

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 ClinicalTrials.gov identifier (NCT number): NCT03100071


Contacts
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Contact: Luljeta Pallaveshi 519-685-8500 ext 55148 Luljeta.Pallaveshi@lhsc.on.ca

Locations
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Canada, Ontario
London Health Science Center, Victoria Hospital Recruiting
London, Ontario, Canada, N6A 5W9
Contact    519-685-8500      
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Anne Marie Clement    613-737-8899      
Sponsors and Collaborators
Michael Kovacs
Ottawa Hospital Research Institute
Jewish General Hospital
Investigators
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Principal Investigator: Michael Kovacs Lawson Health Research Institute

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Responsible Party: Michael Kovacs, Associate Professor, Medical Doctor, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03100071     History of Changes
Other Study ID Numbers: R-17-160
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Upper Extremity Deep Vein Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heparin, Low-Molecular-Weight
Dalteparin
Apixaban
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors