Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters

Launched by OTTAWA HOSPITAL RESEARCH INSTITUTE · Aug 25, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called rivaroxaban can help prevent blood clots in cancer patients who have a central venous catheter (CVC) inserted. Blood clots can be a serious concern for people with cancer, especially those with a CVC, which is a tube placed in a vein to give treatments like chemotherapy. The trial aims to find out if taking a preventive dose of rivaroxaban is both safe and effective for these patients.

To be eligible for this study, participants need to be at least 18 years old and must have a new or existing cancer diagnosis, along with a CVC that was placed within the last 72 hours. However, people who have had their CVC in for more than 72 hours, have certain bleeding risks, or are taking specific medications that could interact with rivaroxaban will not be able to participate. If someone joins the trial, they will receive the study medication and be monitored for their health to see how well it works. This trial is currently recruiting participants, and it's an important step in finding better ways to protect cancer patients from blood clots.

Gender

ALL

Eligibility 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