University Health Network
Toronto, Ontario, M5G 2C4, Canada
Location contact
Jameel Abdulrehman, MD, MSc
CONTACT
NCT Number: NCT06887270
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.
Trial opening soon.
Get NotifiedAll sexes
Interventional
Not applicable
Toronto, Ontario, M5G 2C4, Canada
Jameel Abdulrehman, MD, MSc
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The continued DOAC group will continue their DOAC peri-procedurally as routine without interruption.
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.
Time frame: 1 year
proportion of eligible participants successfully recruited to the study and randomized to a treatment arm
Time frame: 1 year
proportion of screened patients who are eligible
Time frame: 1 year
proportion of recruited participants that adhere to the assigned study intervention
Time frame: 1 year
proportion of recruited participants that complete DOAC level testing
Time frame: 1 year
proportion of recruited participants who attend the follow-up visit
Time frame: 1 year
proportion of recruited participants who completed all study procedures appropriately
Time frame: 1 year
Time frame: 30 days
composite of major bleeding and clinically relevant non-major bleeding at 30 days
Time frame: 30 days
major bleeding at 30 days
Time frame: 30 days
Clinically relevant non-major bleeding at 30 days
Time frame: 30 days
Recurrent venous thromboembolism in those anticoagulated for VTE at 30 days
Time frame: 30 days
Arterial thrombosis in those anticoagulated for AF at 30 days
Time frame: 30 days
All-cause mortality at 30 days
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
University Health Network, Toronto
Other
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
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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