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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity Health Network, Toronto

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Creatinine clearance (Cockcroft-Gault equation) <30 mL/min for Dabigatran, Rivaroxaban, or Edoxaban, and <25mL/min for Apixaban

Diagnosis of VTE within 21 days

Platelet count < 50 x 10^9/L at time of study entry

Concomitant strong inhibitors or inducers to P-glycoprotein and/or CYP-3A4

Trial design

Treatments tested in this trial

  • Continued DOAC
  • Interrupted DOAC

Treatment groups

10 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Health Network, Toronto

Lead sponsor

Helliwell Foundation

Collaborator