Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters
- Registration Number
- NCT05029063
- Lead Sponsor
- Ottawa Hospital Research Institute
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1828
- 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:
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CVC in place for >72 hours
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Patient requires anticoagulation for other indications
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Concomitant use of dual antiplatelet therapy
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Major bleeding event in the last 4 weeks
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Patients receiving concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-gp (such as cobicistat, ketoconazole, itraconazole, posaconazole, or ritonavir).
-
Known pregnancy or plan to become pregnant in next 3 months
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Severe renal insufficiency (Creatinine clearance <30 mL/min (defined by Cockcroft-Gault) in the previous 3 months
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Documented severe liver disease (e.g., acute clinical hepatitis, chronic active hepatitis or cirrhosis) in the previous 3 months
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Known thrombocytopenia (platelet count < 50x 109/L) in the previous 3 months
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Known allergy to rivaroxaban
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Life expectancy <3 months
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History of condition at increased bleeding risk including, but not limited to:
- cerebral infarction (hemorrhagic or ischemic), active peptic ulcer disease with recent bleeding, spontaneous or acquired impairment of hemostasis in the past 4 weeks.
- Chronic hemorrhagic disorder
-
Primary malignancy diagnosis of basal cell or squamous cell carcinoma of the skin only
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Refused or unable to obtain consent
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Rivaroxaban 10 MG Identical Placebo 10mg OD Experimental Rivaroxaban 10 MG Rivaroxaban 10mg OD
- Primary Outcome Measures
Name Time Method Major VTE prevention 90 days (± 3 days) of randomization Number of Major VTE's in patient population
Episodes of Major Bleeding 90 days (± 3 days) of randomization Number of participants who had a major bleed
- Secondary Outcome Measures
Name Time Method CVC Life-span 90 days (± 3 days) of randomization Life span of inserted CVC
Number of patients who benefitted from using the experimental intervention 90 days (± 3 days) of randomization Composite of major VTE and major bleeding
Proximal CVC VTE 90 days (± 3 days) of randomization Incidental and symptomatic proximal (axillary vein or more proximal) upper extremity CVC-related DVT
Number of patients who had a fatal VTE 90 days (± 3 days) of randomization Fatal VTE
Distal CVC VTE 90 days (± 3 days) of randomization Incidental and symptomatic distal (brachial vein) or proximal (axillary vein or more proximal) upper extremity CVC-related DVT
Number of participants with Unusual site thrombosis including: splanchnic vein (portal, splenic, superior mesenteric, inferior mesenteric, hepatic) cerebral vein, renal or gonadal vein thromboses 90 days (± 3 days) of randomization Unusual site thrombosis including: splanchnic vein (portal, splenic, superior mesenteric, inferior mesenteric, hepatic) cerebral vein, renal or gonadal vein thromboses
Number of participants with Clinically Relevant Non-Major Bleeding (CRNMB) 90 days (± 3 days) of randomization As defined by ISTH
Proximal Lower extremity DVT 90 days (± 3 days) of randomization Incidental and symptomatic proximal (popliteal vein or more proximal) lower extremity DVT
Distal Lower extremity DVT 90 days (± 3 days) of randomization Incidental and symptomatic distal or proximal (popliteal vein or more proximal) lower extremity DVT
Number of participants with an arterial thromboembolic event including: MI, stroke, peripheral arterial disease 90 days (± 3 days) of randomization Arterial thromboembolic events defined as a diagnostically confirmed final clinical diagnosis of myocardial infarction, stroke or peripheral arterial disease involving the following arterial vascular beds: carotid, upper or lower extremity, gastrointestinal tract, liver, spleen, or kidney
PE 90 days (± 3 days) of randomization Incidental and Symptomatic
Number of patients with CVC occlusion occurring after the start of therapy, defined as an obstruction of the CVC lumen that prevents or limits the ability to flush, withdraw blood and/or administer solutions or medications. 90 days (± 3 days) of randomization CVC occlusion occurring after the start of therapy, defined as an obstruction of the CVC lumen that prevents or limits the ability to flush, withdraw blood and/or administer solutions or medications.
Number of participants with Superficial upper or lower extremity vein thrombosis 90 days (± 3 days) of randomization Superficial upper or lower extremity vein thrombosis
Number of patients with CVC-related blood stream infection defined as the presence of bacteremia originating from the CVC according to the definition from the Centers for Disease Control and Prevention 90 days (± 3 days) of randomization CVC-related blood stream infection defined as the presence of bacteremia originating from the CVC according to the definition from the Centers for Disease Control and Prevention
Number of participants who passed away during the trial 90 days (± 3 days) of randomization Overall mortality
ICER 1 Year Incremental cost-effectiveness ratio (ICER) at one year
EQ-5D-5L Health-related quality of life 90 days (± 3 days) of randomization Health-related quality of life
Trial Locations
- Locations (7)
HHS - Juravinski Hospital
🇨🇦Hamilton, Ontario, Canada
Sault Area Hospital
🇨🇦Sault Ste Marie, Ontario, Canada
Ottawa Hospital Research Institute- The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Windsor Regional Hospital
🇨🇦Windsor, Ontario, Canada
CISSS Montérégie-Centre HOPITAL CHARLES LEMOYNE
🇨🇦Greenfield Park, Quebec, Canada
Niagara Health
🇨🇦St. Catharines, Ontario, Canada