Clinical Trial

Peri-procedural Management of Direct Oral Anticoagulants for Central VENOus Catheters in CAncer Patients With Venous Thromboembolism or Atrial Fibrillation Pilot Study

Study acronym: VENO CAT
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT06887270
Lead Sponsor University Health Network, Toronto
Collaborators: Helliwell Foundation
Conditions Anticoagulant-induced Bleeding, Direct Oral Anticoagulant, Cancer, Central Venous Catheter, Periprocedural Complication
Enrollment 10 participants
Start Date 2025-09
Primary Completion 2026-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2025-03-20