| Titre |
Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters: a Randomized Controlled Trial |
| Protocole ID |
TRIM-Line 3698 |
| ClinicalTrials.gov ID |
NCT05029063 |
| Type(s) de cancer |
Contrôle des symptômes |
| Phase |
|
| Type étude |
Support |
| Médicament |
Rivaroxaban 10 MG |
| Institution |
CISSS DE CHAUDIERE-APPALACHES
 HOTEL-DIEU DE LEVIS
143 rue Wolfe, Lévis, QC, G6V 3Z1
|
| Ville |
Beauceville |
| Investigateur(trice) principal(e) |
Dr Frédéric Larose
|
| Coordonnateur(trice) |
Pierre Bédard
418-835-7121
|
| Statut |
 Actif en recrutement |
| Date d'activation |
16-11-2023 |
| Critètes d'éligibilité |
- Patients 18 years of age or older with a new or existing diagnosis of cancer and a CVC inserted in the last 72 hours.
|
| Critètes d'exclusion |
- 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
|
Groupe d'étude en oncologie du Québec