Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Helliwell Foundation | UNKNOWN |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continued DOAC | Experimental | 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. |
|
| Interrupted DOAC | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continued DOAC | Other | The continued DOAC group will continue their DOAC peri-procedurally as routine without interruption. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | proportion of eligible participants successfully recruited to the study and randomized to a treatment arm | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Eligibility rate | proportion of screened patients who are eligible | 1 year |
| Intervention adherence | proportion of recruited participants that adhere to the assigned study intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically significant bleeding | composite of major bleeding and clinically relevant non-major bleeding at 30 days | 30 days |
| Major bleeding | major bleeding at 30 days |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network | Toronto | Ontario | M5G 2C4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41722271 | Derived | Abdulrehman J, Shaw JR, Stella SF, Mafeld S, Douketis J, Selby R, Gross P, Carrier M. Peri-procedural anticoagulation management for central venous catheter insertion in persons with cancer. Thromb Res. 2026 Mar;259:109620. doi: 10.1016/j.thromres.2026.109620. Epub 2026 Feb 14. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Interrupted DOAC | Other | 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. |
|
| 1 year |
| DOAC level adherence | proportion of recruited participants that complete DOAC level testing | 1 year |
| Retention rate | proportion of recruited participants who attend the follow-up visit | 1 year |
| Study completion rate | proportion of recruited participants who completed all study procedures appropriately | 1 year |
| Reasons for declining participation | 1 year |
| 30 days |
| Clinically relevant non-major bleeding | Clinically relevant non-major bleeding at 30 days | 30 days |
| Recurrent venous thromboembolism | Recurrent venous thromboembolism in those anticoagulated for VTE at 30 days | 30 days |
| Arterial thrombosis | Arterial thrombosis in those anticoagulated for AF at 30 days | 30 days |
| All-cause mortality | All-cause mortality at 30 days | 30 days |
| DOAC levels | A pre-procedural DOAC level will be drawn by blood sample in all participants on Day 0, within two hours of CVC insertion | within 2 hours of CVC insertion |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided