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

Last updated: March 13, 2025
Sponsor: University Health Network, Toronto
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Venous Thromboembolism

Chest Pain

Venous Thrombosis

Treatment

Continued DOAC

Interrupted DOAC

Clinical Study ID

NCT06887270
25-5249
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult patients with VTE or non-valvular AF on prophylactic or therapeutic dose DOAC

  2. Active cancer, defined as diagnosed within the past 6 months; or recurrent,regionally advanced, or metastatic cancer; or for which treatment had beenadministered within 6 months of port or tunneled CVC insertion; or hematologiccancer not in complete remission

  3. Pending elective radiologically guided insertion of tunneled or port CVC

  4. Able and willing to adhere to peri-procedural DOAC management plan and follow-up

Exclusion

Exclusion Criteria:

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

  2. Diagnosis of VTE within 21 days

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

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

Study Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: Continued DOAC
Phase:
Study Start date:
September 01, 2025
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • University Health Network

    Toronto, Ontario M5G 2C4
    Canada

    Site Not Available

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