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Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters

Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters

Recruiting
18 years and older
All
Phase 3

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Overview

The purpose of the full trial is to determine the efficacy and safety of prophylactic dose rivaroxaban to prevent VTE among cancer patients with CVC.

Description

TRIM-Line is a double blind randomized controlled trial comparing rivaroxaban 10mg po daily vs placebo in patients with active cancer and indwelling CVC. This will involve 9 centers across Canada.

Eligibility

Inclusion Criteria:

  • Patients 18 years of age or older with a new or existing diagnosis of cancer and a CVC inserted in the last 72 hours.

Exclusion criteria:

  1. CVC in place for >72 hours
  2. Patient requires anticoagulation for other indications
  3. Concomitant use of dual antiplatelet therapy
  4. Major bleeding event in the last 4 weeks
  5. Patients receiving concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-gp (such as cobicistat, ketoconazole, itraconazole, posaconazole, or ritonavir).
  6. Known pregnancy or plan to become pregnant in next 3 months
  7. Severe renal insufficiency (Creatinine clearance <30 mL/min (defined by Cockcroft-Gault) in the previous 3 months
  8. Documented severe liver disease (e.g., acute clinical hepatitis, chronic active hepatitis or cirrhosis) in the previous 3 months
  9. Known thrombocytopenia (platelet count < 50x 109/L) in the previous 3 months
  10. Known allergy to rivaroxaban
  11. Life expectancy <3 months
  12. History of condition at increased bleeding risk including, but not limited to:
    1. cerebral infarction (hemorrhagic or ischemic), active peptic ulcer disease with recent bleeding, spontaneous or acquired impairment of hemostasis in the past 4 weeks.
    2. Chronic hemorrhagic disorder
  13. Primary malignancy diagnosis of basal cell or squamous cell carcinoma of the skin

    only

  14. Refused or unable to obtain consent

Study details
    Venous Thromboembolism
    Cancer

NCT05029063

Ottawa Hospital Research Institute

16 July 2025

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