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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06887270
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-13
• Study First Posted: 2025-03-20
• Last Update Posted: 2025-03-20
• Study Start: 2025-09
• Primary Completion: 2026-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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 been administered within 6 months of port or tunneled CVC insertion; or hematologic cancer 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 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recruitment rate	1 year	proportion of eligible participants successfully recruited to the study and randomized to a treatment arm

Secondary Outcome Measures

Name	Time	Method
Eligibility rate	1 year	proportion of screened patients who are eligible
Intervention adherence	1 year	proportion of recruited participants that adhere to the assigned study intervention
DOAC level adherence	1 year	proportion of recruited participants that complete DOAC level testing
Retention rate	1 year	proportion of recruited participants who attend the follow-up visit
Study completion rate	1 year	proportion of recruited participants who completed all study procedures appropriately
Reasons for declining participation	1 year

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada