Peri-procedural Management of Direct Oral Anticoagulants for Central VENOus Catheters in CAncer Patients With Venous Thromboembolism or Atrial Fibrillation (VENOCAT) Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Recruitment rate
Study Overview
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 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Continued DOAC
The continued DOAC group will continue their DOAC peri-procedurally as routine without interruption.
This management strategy was devised based on the cardiac device insertion studies which found continued AC to be a safe and efficacious strategy for cardiac device insertion, which is procedurally similar to tunneled or port CVC insertion. This is the peri-procedural AC strategy for tunneled or port CVC insertion suggested by the Society of Interventional Radiology guidelines.
Intervention: Continued DOAC (Other)
Interrupted DOAC
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. This management strategy was utilized in the PAUSE study and was devised taking into account DOAC half-lives, manufacturer recommendations, and available literature. With this strategy, DOACs would be interrupted for three to four halflives, resulting in minimal residual anticoagulant effect. DOAC interruption is described by number of days rather than hours to allow for a simple pragmatic strategy that would be easy to apply in practice and follow by patients. This strategy was found to be safe and efficacious in the PAUSE and cardiac device insertion studies. This is the peri-procedural AC strategy for tunneled or port CVC insertion suggested by the ISTH.
Intervention: Interrupted DOAC (Other)
Outcomes
Primary Outcomes
Recruitment rate
Time Frame: 1 year
proportion of eligible participants successfully recruited to the study and randomized to a treatment arm
Secondary Outcomes
- Eligibility rate(1 year)
- Intervention adherence(1 year)
- Reasons for declining participation(1 year)
- DOAC level adherence(1 year)
- Retention rate(1 year)
- Study completion rate(1 year)