Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters (TRIM-Line)

Ottawa Hospital Research Institute

Status and phase: Enrolling; Phase 3

Conditions: Venous Thromboembolism; Cancer

Treatments: Drug: Rivaroxaban 10 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05029063

TRIM-Line 3698

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,828 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,828 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

Rivaroxaban 10mg OD

Treatment:

Drug: Rivaroxaban 10 MG

Control

Placebo Comparator group

Description:

Identical Placebo 10mg OD

Treatment:

Drug: Rivaroxaban 10 MG