Anticoagulant-induced Bleeding, Cancer, Central Venous Catheter, Direct Oral Anticoagulant, Periprocedural Complication
Conditions
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.
Interventions
OTHERContinued DOAC
The continued DOAC group will continue their DOAC peri-procedurally as routine without interruption.
OTHERInterrupted 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.
Sponsors
Helliwell Foundation
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Adult patients with VTE or non-valvular AF on prophylactic or therapeutic dose DOAC 2. 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 3. Pending elective radiologically guided insertion of tunneled or port CVC 4. Able and willing to adhere to peri-procedural DOAC management plan and follow-up
Exclusion criteria
1. Creatinine clearance (Cockcroft-Gault equation) \<30 mL/min for Dabigatran, Rivaroxaban, or Edoxaban, and \<25mL/min for Apixaban 2. Diagnosis of VTE within 21 days 3. Platelet count \< 50 x 10\^9/L at time of study entry 4. Concomitant strong inhibitors or inducers to P-glycoprotein and/or CYP-3A4
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 1 year | proportion of eligible participants successfully recruited to the study and randomized to a treatment arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eligibility rate | 1 year | proportion of screened patients who are eligible |
| Intervention adherence | 1 year | proportion of recruited participants that adhere to the assigned study intervention |
| DOAC level adherence | 1 year | proportion of recruited participants that complete DOAC level testing |
| Retention rate | 1 year | proportion of recruited participants who attend the follow-up visit |
| Study completion rate | 1 year | proportion of recruited participants who completed all study procedures appropriately |
| Reasons for declining participation | 1 year | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinically significant bleeding | 30 days | composite of major bleeding and clinically relevant non-major bleeding at 30 days |
| Major bleeding | 30 days | major bleeding at 30 days |
| Clinically relevant non-major bleeding | 30 days | Clinically relevant non-major bleeding at 30 days |
| Recurrent venous thromboembolism | 30 days | Recurrent venous thromboembolism in those anticoagulated for VTE at 30 days |
| Arterial thrombosis | 30 days | Arterial thrombosis in those anticoagulated for AF at 30 days |
| All-cause mortality | 30 days | All-cause mortality at 30 days |
| DOAC levels | within 2 hours of CVC insertion | A pre-procedural DOAC level will be drawn by blood sample in all participants on Day 0, within two hours of CVC insertion |
Countries
Canada
Outcome results
None listed