About this trial
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 clinical problem, with conflicting management advice from guidelines and resultant uncertainty for best practices. Data from prospective studies assessing peri-procedural DOAC management exist; however, these data pertain to procedures in the general population. These management strategies may not be applicable to PWC because (1) although CVC insertion is a low risk, image-guided specialized procedure, (2) PWC are at considerably higher risk of peri-procedural bleeding and thrombosis than non-PWC. It is not surprising, therefore, that guideline recommendations and current practices vary widely. To resolve management uncertainty and establish a standard-of-care, the VENOCAT pilot randomized controlled trial (RCT) is a first step that will assess the feasibility of a definitive trial comparing continued vs. interrupted DOAC management in PWC undergoing tunneled or port CVC insertion. Evidence is needed to standardize clinical practice and reduce the risk of bleeding and thrombotic complications.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Continued DOAC
- Interrupted DOAC
Treatment groups
Sponsors and collaborators
University Health Network, Toronto
Lead sponsor
Helliwell Foundation
Collaborator