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

Last updated: July 30, 2021
Sponsor: Michael Kovacs
Overall Status: Active - Recruiting

Phase

N/A

Condition

Venous Thrombosis

Thrombosis

Venous Thromboembolism

Treatment

N/A

Clinical Study ID

NCT03100071
R-17-160
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female > 18 years of age.
  2. Symptomatic acute upper limb thrombosis in the axillary, subclavian or internaljugular veins, with or without pulmonary embolism, associated with central venouscatheter objectively documented by compression ultrasonography, venogram orComputerized Tomography (CT) scan.
  3. Diagnosis of active malignancy, as defined by patients who are either receiving activetreatment, or have metastatic disease or who have been diagnosed within the past twoyears.
  4. Willing to provide written informed consent.

Exclusion

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 thrombolytictherapy (2 mg tPA).
  8. Patients with Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL) ormultiple myeloma with a bone marrow or stem cell transplant planned within the next 3months
  9. Treatment for current episode > 7 days with any acceptable anticoagulant therapy
  10. Concomitant use of p-glucoprotein and Cytochrome P450 3A4 (CYP3A4) inhibitors (forexample azole antifungals such as ketoconazole) or inducers (for example rifampicin,antiepileptics)
  11. Recent coronary artery stent requiring dual anti-platelet therapy (for exampleacetylsalicylic acid [ASA] and Plavix)
  12. If female of childbearing potential: pregnancy and/or breastfeeding

Study Design

Total Participants: 70
Study Start date:
May 15, 2017
Estimated Completion Date:
August 31, 2021

Study 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.

Connect with a study center

  • London Health Science Center, Victoria Hospital

    London, Ontario N6A 5W9
    Canada

    Active - Recruiting

  • Ottawa Hospital Research Institute

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

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