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)

Nova Scotia Health

Halifax, Nova Scotia, Canada

William Osler Health System

Brampton, Ontario, Canada

HHS - Juravinski Hospital

Hamilton, Ontario, Canada

Ottawa Hospital Research Institute- The Ottawa Hospital

Ottawa, Ontario, Canada

Sault Area Hospital

Sault Ste. Marie, Ontario, Canada

Niagara Health

St. Catharines, Ontario, Canada

Windsor Regional Hospital

Windsor, Ontario, Canada

CISSS Montérégie-Centre HOPITAL CHARLES LEMOYNE

Greenfield Park, Quebec, Canada

Centre Intégré de santé et de services sociaux de Chaudière-Appalaches

Lévis, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

McGill University Health Center

Montreal, Quebec, Canada

View Full Details on ClinicalTrials.gov

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NCT05029063


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