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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
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
Trial sites (11)
Facility
City
Region
Status
Nova Scotia Health
Halifax
Nova Scotia
Recruiting
William Osler Health System
Brampton
Ontario
Recruiting
HHS - Juravinski Hospital
Hamilton
Ontario
Recruiting
Ottawa Hospital Research Institute- The Ottawa Hospital
Ottawa
Ontario
Recruiting
Sault Area Hospital
Sault Ste. Marie
Ontario
Recruiting
Niagara Health
St. Catharines
Ontario
Recruiting
Windsor Regional Hospital
Windsor
Ontario
Recruiting
CISSS Montérégie-Centre HOPITAL CHARLES LEMOYNE
Greenfield Park
Quebec
Recruiting
Centre Intégré de santé et de services sociaux de Chaudière-Appalaches
Lévis
Quebec
Recruiting
Jewish General Hospital
Montreal
Quebec
Recruiting
McGill University Health Center
Montreal
Quebec
Recruiting
More Ottawa Hospital Research Institute trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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