RecruitingPhase 3NCT05029063
Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters
Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters: a Randomized Controlled Trial
Sponsor
Ottawa Hospital Research Institute
Enrollment
1,828 participants
Start Date
Oct 5, 2022
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria1
- 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 Criteria16
- CVC in place for >72 hours
- Patient requires anticoagulation for other indications
- Concomitant use of dual antiplatelet therapy
- Major bleeding event in the last 4 weeks
- 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
- Severe renal insufficiency (Creatinine clearance <30 mL/min (defined by Cockcroft-Gault) in the previous 3 months
- Documented severe liver disease (e.g., acute clinical hepatitis, chronic active hepatitis or cirrhosis) in the previous 3 months
- Known thrombocytopenia (platelet count < 50x 109/L) in the previous 3 months
- Known allergy to rivaroxaban
- Life expectancy <3 months
- 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
- Refused or unable to obtain consent
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Interventions
DRUGRivaroxaban 10 MG
Identical comparator drug
Locations(11)
View Full Details on ClinicalTrials.gov
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NCT05029063
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