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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Central Venous Catheter; Anticoagulant-induced Bleeding; Periprocedural Complication; Direct Oral Anticoagulant
• Intervention / Treatment: Other: Continued DOAC; Other: Interrupted DOAC

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • University Health Network
      • Contact: Jameel Abdulrehman, MD, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continued DOAC; The continued DOAC group will continue their DOAC peri-procedurally as routine without interruption. This management strategy was devised based on the cardiac device insertion studies which found continued AC to be a safe and efficacious strategy for cardiac device insertion, which is procedurally similar to tunneled or port CVC insertion. This is the peri-procedural AC strategy for tunneled or port CVC insertion suggested by the Society of Interventional Radiology guidelines.	Other: Continued DOAC; The continued DOAC group will continue their DOAC peri-procedurally as routine without interruption.
Active Comparator: Interrupted DOAC; The interrupted DOAC group will take their last DOAC dose on Day -2, unless their DOAC is Dabigatran and their creatinine clearance is < 50mL/min (Cockcroft-Gault equation), in which their last dose will be on Day -3. The DOAC will be resumed on Day +1. This management strategy was utilized in the PAUSE study and was devised taking into account DOAC half-lives, manufacturer recommendations, and available literature. With this strategy, DOACs would be interrupted for three to four halflives, resulting in minimal residual anticoagulant effect. DOAC interruption is described by number of days rather than hours to allow for a simple pragmatic strategy that would be easy to apply in practice and follow by patients. This strategy was found to be safe and efficacious in the PAUSE and cardiac device insertion studies. This is the peri-procedural AC strategy for tunneled or port CVC insertion suggested by the ISTH.	Other: Interrupted DOAC; The interrupted DOAC group will take their last DOAC dose on Day -2, unless their DOAC is Dabigatran and their creatinine clearance is < 50mL/min (Cockcroft-Gault equation), in which their last dose will be on Day -3. The DOAC will be resumed on Day +1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	proportion of eligible participants successfully recruited to the study and randomized to a treatment arm	1 year

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically significant bleeding	composite of major bleeding and clinically relevant non-major bleeding at 30 days	30 days
Major bleeding	major bleeding at 30 days	30 days
Clinically relevant non-major bleeding	Clinically relevant non-major bleeding at 30 days	30 days
Recurrent venous thromboembolism	Recurrent venous thromboembolism in those anticoagulated for VTE at 30 days	30 days
Arterial thrombosis	Arterial thrombosis in those anticoagulated for AF at 30 days	30 days
All-cause mortality	All-cause mortality at 30 days	30 days
DOAC levels	A pre-procedural DOAC level will be drawn by blood sample in all participants on Day 0, within two hours of CVC insertion	within 2 hours of CVC insertion

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Helliwell Foundation

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: March 13, 2025
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Embolism and Thrombosis; Atrial Fibrillation; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: 25-5249

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No