Status:
NOT_YET_RECRUITING
Peri-procedural Management of Direct Oral Anticoagulants for Central VENOus Catheters in CAncer Patients With Venous Thromboembolism or Atrial Fibrillation Pilot Study
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Helliwell Foundation
Conditions:
Anticoagulant-induced Bleeding
Direct Oral Anticoagulant
Eligibility:
All Genders
Phase:
NA
Brief Summary
The peri-procedural management of direct oral anticoagulants (DOACs) in persons with cancer (PWC) undergoing tunneled or port central venous catheter (CVC) insertion is a common but understudied clini...
Eligibility Criteria
Inclusion
- Adult patients with VTE or non-valvular AF on prophylactic or therapeutic dose DOAC
- Active cancer, defined as diagnosed within the past 6 months; or recurrent, regionally advanced, or metastatic cancer; or for which treatment had been administered within 6 months of port or tunneled CVC insertion; or hematologic cancer not in complete remission
- Pending elective radiologically guided insertion of tunneled or port CVC
- Able and willing to adhere to peri-procedural DOAC management plan and follow-up
Exclusion
- Creatinine clearance (Cockcroft-Gault equation) \<30 mL/min for Dabigatran, Rivaroxaban, or Edoxaban, and \<25mL/min for Apixaban
- Diagnosis of VTE within 21 days
- Platelet count \< 50 x 10\^9/L at time of study entry
- Concomitant strong inhibitors or inducers to P-glycoprotein and/or CYP-3A4
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06887270
Start Date
September 1 2025
End Date
September 1 2027
Last Update
March 20 2025
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5G 2C4