NCT06887270Not yet recruiting
Peri-procedural Management of Direct Oral Anticoagulants for Central VENOus Catheters in CAncer Patients With Venous Thromboembolism or Atrial Fibrillation Pilot Study
Peri-procedural Management of Direct Oral Anticoagulants for Central VENOus Catheters in CAncer Patients With Venous Thromboembolism or Atrial Fibrillation (VENOCAT) Pilot Study
Source: ClinicalTrials.gov · Last updated 20 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 13 Mar 2025
- Start date
- Sept 2025
- Primary completion date
- Sept 2026
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Atrial fibrillation, Childhood cancers
- NCT number
- NCT06887270
What you commit to
- Study type: Interventional
- Planned participants: 10
- From Sept 2025 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant strong inhibitors or inducers to P-glycoprotein and/or CYP-3A4
Lab values
- Creatinine clearance (Cockcroft-Gault equation) \<30 mL/min for Dabigatran, Rivaroxaban, or Edoxaban, and \<25mL/min for Apixaban
- Platelet count \< 50 x 10\^9/L at time of study entry
Other
- Diagnosis of VTE within 21 days
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
Related publications
- Peri-procedural anticoagulation management for central venous catheter insertion in persons with cancer.Thromb Res · 2026 · PMID 41722271
This page is information, not medical advice. Discuss any trial with your doctor.