Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters
Cancer | Venous ThromboembolismThe purpose of the full trial is to determine the efficacy and safety of prophylactic dose rivaroxaban to prevent VTE among cancer patients with CVC.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
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 Location
Ottawa Hospital Research Institute- The Ottawa Hospital
Ottawa Hospital Research Institute- The Ottawa HospitalOttawa, Ontario
Canada
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CISSS Montérégie-Centre HOPITAL CHARLES LEMOYNE
CISSS Montérégie-Centre HOPITAL CHARLES LEMOYNEGreenfield Park, Quebec
Canada
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HHS - Juravinski Hospital
HHS - Juravinski HospitalHamilton, Ontario
Canada
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Windsor Regional Hospital
Windsor Regional HospitalWindsor, Ontario
Canada
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Sault Area Hospital
Sault Area HospitalSault Ste Marie, Ontario
Canada
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Jewish General Hospital
Jewish General HospitalMontreal, Quebec
Canada
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Niagara Health
Niagara HealthSt. Catharines, Ontario
Canada
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- Study Sponsored By
- Ottawa Hospital Research Institute
- Participants Required
- More Information
- Study ID:
NCT05029063