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Not yet recruiting NCT06887270

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

No phase Interventional Anticoagulant-induced Bleeding Direct Oral Anticoagulant Cancer Central Venous Catheter

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Continued DOAC, Interrupted DOAC.
Who it may be relevant to
Registry conditions: Anticoagulant-induced Bleeding, Direct Oral Anticoagulant, Cancer, Central Venous Catheter. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Recruitment rate [Time frame: 1 year]
Secondary outcome measures (6)
  • Eligibility rate [Time frame: 1 year]
  • Intervention adherence [Time frame: 1 year]
  • DOAC level adherence [Time frame: 1 year]
  • Retention rate [Time frame: 1 year]
  • Study completion rate [Time frame: 1 year]
  • Reasons for declining participation [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • University Health Network — Toronto

Publications

  • Abdulrehman J, Shaw JR, Stella SF, Mafeld S, Douketis J, Selby R, Gross P, Carrier M. Peri-procedural anticoagulation management for central venous catheter insertion in persons with cancer. Thromb Res. 2026 Mar;259:109620. doi: 10.1016/j.thromres.2026.109620. Epub 2026 Feb 14. PMID 41722271

Identifiers

NCT: NCT06887270 · 25-5249

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗