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

NCT06887270 NA NOT_YET_RECRUITING

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.

Details

Lead sponsor	University Health Network, Toronto
Phase	NA
Status	NOT_YET_RECRUITING
Enrolment	10
Start date	2025-09
Completion	2027-09

Conditions

• Anticoagulant-induced Bleeding
• Direct Oral Anticoagulant
• Cancer
• Central Venous Catheter
• Periprocedural Complication

Interventions

• Continued DOAC
• Interrupted DOAC

Primary outcomes

• Recruitment rate — 1 year
  proportion of eligible participants successfully recruited to the study and randomized to a treatment arm

Countries

Canada