Clinical trial NCT06887270: Peri-procedural Management of Direct Oral Anticoagulants for Central VENOus Catheters in CAncer Patients With Venous Thromboembolism or Atrial Fibrillation Pilot Study
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anticoagulant-induced Bleeding
Direct Oral Anticoagulant
Cancer
Central Venous Catheter
Periprocedural Complication
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Helliwell Foundation
First posted: 2025-03-20
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Recruitment rate
timeFrame: 1 year
Secondary outcomes:
measure: Eligibility rate
timeFrame: 1 year
measure: Intervention adherence
timeFrame: 1 year
measure: DOAC level adherence
timeFrame: 1 year
measure: Retention rate
timeFrame: 1 year
measure: Study completion rate
timeFrame: 1 year
measure: Reasons for declining participation
timeFrame: 1 year
Other outcomes:
measure: Clinically significant bleeding
timeFrame: 30 days
measure: Major bleeding
timeFrame: 30 days
measure: Clinically relevant non-major bleeding
timeFrame: 30 days
measure: Recurrent venous thromboembolism
timeFrame: 30 days
measure: Arterial thrombosis
timeFrame: 30 days
measure: All-cause mortality
timeFrame: 30 days
measure: DOAC levels
timeFrame: within 2 hours of CVC insertion
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
References: