Contrôle des symptômes

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TITRE (EN) Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters: a Randomized Controlled Trial
PROTOCOLE ID TRIM-Line 3698
CLINICAL TRIAL.gov ID NCT05029063
TYPE(S) DE CANCER Contrôle des symptômes
PHASE
TYPE D'ÉTUDE Support
INSTITUTION CISSS DE LA MONTEREGIE-CENTRE
3120 boulevard Taschereau
(450) 466-5000
VILLE Greenfield Park
INVESTIGATEUR(RICE) PRINCIPAL(E) Catherine Sperlich
COORDONATEUR(RICE) Caroline Millette
caroline.millette.cisssmc16@ssss.gouv.qc.ca
450-466-5000 poste 3276
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • Patients 18 years of age or older with a new or existing diagnosis of cancer and a CVC inserted in the last 72 hours.
CRITÈRES D'EXCLUSION (EN)
  • 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