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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
10
The continued DOAC group will continue their DOAC peri-procedurally as routine without interruption.
The 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.
University Health Network
Toronto, Ontario, Canada
Recruitment rate
proportion of eligible participants successfully recruited to the study and randomized to a treatment arm
Time frame: 1 year
Eligibility rate
proportion of screened patients who are eligible
Time frame: 1 year
Intervention adherence
proportion of recruited participants that adhere to the assigned study intervention
Time frame: 1 year
DOAC level adherence
proportion of recruited participants that complete DOAC level testing
Time frame: 1 year
Retention rate
proportion of recruited participants who attend the follow-up visit
Time frame: 1 year
Study completion rate
proportion of recruited participants who completed all study procedures appropriately
Time frame: 1 year
Reasons for declining participation
Time frame: 1 year
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