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

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Mar 13, 2025

Trial Information

Current as of April 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

The VENOCAT trial aims to find the best way to manage a type of blood thinner called direct oral anticoagulants (DOACs) for cancer patients who need a central venous catheter (CVC). This is a thin tube placed in a vein to help with treatments like chemotherapy. It’s important to manage blood thinners carefully because patients with cancer have a higher risk of bleeding or blood clots during and after the procedure. Currently, there are different opinions on how to handle this, and the trial will help determine whether it’s safer for patients to continue taking their DOACs or to stop them for a short time before the procedure.

To be eligible for the trial, participants should be adults with cancer who are currently using DOACs and are scheduled for a planned CVC insertion. They should also be able to follow the management plan during the procedure. Unfortunately, those with certain kidney issues, recent blood clots, very low platelet counts, or specific medication interactions cannot participate. If you join the trial, you can expect close monitoring and follow-up regarding your blood thinner management during the CVC insertion, which could help improve safety for patients in similar situations in the future.

Gender

ALL

Eligibility criteria

  • 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

About University Health Network, Toronto

University Health Network (UHN), based in Toronto, is a leading academic health sciences center dedicated to advancing patient care through innovative research and education. As a prominent sponsor of clinical trials, UHN integrates cutting-edge scientific discoveries with clinical practice, facilitating the development of new therapies and treatment modalities. With a commitment to improving health outcomes, UHN collaborates with a diverse network of researchers, healthcare professionals, and industry partners, fostering an environment that prioritizes patient safety and ethical standards in clinical research. Through its extensive resources and expertise, UHN plays a pivotal role in transforming healthcare and enhancing the quality of life for patients both locally and globally.

Locations

Toronto, Ontario, Canada

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported