Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters

Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters: a Randomized Controlled Trial

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.

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.

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