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Clinical Trials in Canada / NCT06887270
Starting soon Not applicable

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

NCT06887270 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2025-09
Last updated
2025-03-20

Condition(s) studied

Anticoagulant-induced BleedingDirect Oral AnticoagulantCancerCentral Venous CatheterPeriprocedural Complication

Investigational drug(s) / intervention(s)

Continued DOACInterrupted DOAC

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

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.

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

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University Health Network Toronto Ontario

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06887270 on ClinicalTrials.gov ↗ ← All trials in Canada