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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Continued DOAC
Other interventionThe continued DOAC group will continue their DOAC peri-procedurally as routine without interruption.
Interrupted DOAC
Other interventionThe interrupted DOAC group will take their last DOAC dose on Day -2, unless their DOAC is Dabigatran and their creatinine clearance is \< 50mL/min (Cockcroft-Gault equation), in which their last dose will be on Day -3. The DOAC will be resumed on Day +1.
Treatment groups
Trial outcomes
Primary outcomes
Recruitment rate
proportion of eligible participants successfully recruited to the study and randomized to a treatment arm
Secondary outcomes
Eligibility rate
proportion of screened patients who are eligible
Intervention adherence
proportion of recruited participants that adhere to the assigned study intervention
DOAC level adherence
proportion of recruited participants that complete DOAC level testing
Retention rate
proportion of recruited participants who attend the follow-up visit
Other outcomes
Clinically significant bleeding
composite of major bleeding and clinically relevant non-major bleeding at 30 days
Major bleeding
major bleeding at 30 days
Clinically relevant non-major bleeding
Clinically relevant non-major bleeding at 30 days
Recurrent venous thromboembolism
Recurrent venous thromboembolism in those anticoagulated for VTE at 30 days
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Health Network, Toronto
Lead sponsor
Helliwell Foundation
Collaborator
This trial is not recruiting at the moment. You can still explore other options: