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NCT Number: NCT06887270

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location contact

Jameel Abdulrehman, MD, MSc

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Continued DOAC

Other

The continued DOAC group will continue their DOAC peri-procedurally as routine without interruption.

Interrupted DOAC

Other

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.

Primary outcomes

  1. Recruitment rate

    Time frame: 1 year

    proportion of eligible participants successfully recruited to the study and randomized to a treatment arm

Secondary outcomes

  1. Eligibility rate

    Time frame: 1 year

    proportion of screened patients who are eligible

  2. Intervention adherence

    Time frame: 1 year

    proportion of recruited participants that adhere to the assigned study intervention

  3. DOAC level adherence

    Time frame: 1 year

    proportion of recruited participants that complete DOAC level testing

  4. Retention rate

    Time frame: 1 year

    proportion of recruited participants who attend the follow-up visit

  5. Study completion rate

    Time frame: 1 year

    proportion of recruited participants who completed all study procedures appropriately

  6. Reasons for declining participation

    Time frame: 1 year

Other outcomes

  1. Clinically significant bleeding

    Time frame: 30 days

    composite of major bleeding and clinically relevant non-major bleeding at 30 days

  2. Major bleeding

    Time frame: 30 days

    major bleeding at 30 days

  3. Clinically relevant non-major bleeding

    Time frame: 30 days

    Clinically relevant non-major bleeding at 30 days

  4. Recurrent venous thromboembolism

    Time frame: 30 days

    Recurrent venous thromboembolism in those anticoagulated for VTE at 30 days

  5. Arterial thrombosis

    Time frame: 30 days

    Arterial thrombosis in those anticoagulated for AF at 30 days

  6. All-cause mortality

    Time frame: 30 days

    All-cause mortality at 30 days

  7. DOAC levels

    Time frame: within 2 hours of CVC insertion

    A pre-procedural DOAC level will be drawn by blood sample in all participants on Day 0, within two hours of CVC insertion

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Helliwell Foundation

Registry information

Official study title

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

Acronym: VENO CAT

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 20, 2025
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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