Anticoagulant-induced BleedingVENO CATNCT06887270
Peri-procedural Management of Direct Oral Anticoagulants for Central VENOus Catheters in CAncer Patients With Venous Thromboembolism or Atrial Fibrillation Pilot Study
A study testing Continued DOAC and Interrupted DOAC in people with Anticoagulant-induced Bleeding and Direct Oral Anticoagulant, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anticoagulant-induced Bleeding, Direct Oral Anticoagulant, Cancer
- What is being tested?
- Continued DOAC and Interrupted DOAC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
University Health Network
Toronto, Ontario, M5G 2C4
Jameel Abdulrehman, MD, MSc
About this 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
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.
- Conditions
- Anticoagulant-induced Bleeding, Direct Oral Anticoagulant, Cancer, Central Venous Catheter, Periprocedural Complication
- Being tested
- Continued DOAC, Interrupted DOAC
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continued DOACOther
The continued DOAC group will continue their DOAC peri-procedurally as routine without interruption.
Interrupted DOACOther
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 group | Role | What they receive |
|---|---|---|
| Continued DOAC | Experimental | The continued DOAC group will continue their DOAC peri-procedurally as routine without interruption.
This management strategy was devised based on the cardiac device insertion studies which found continued AC to be a safe and efficacious strategy for cardiac device insertion, which is procedurally similar to tunneled or port CVC insertion. This is the peri-procedural AC strategy for tunneled or port CVC insertion suggested by the Society of Interventional Radiology guidelines. Receives: Other: Continued DOAC |
| Interrupted DOAC | Active comparator | 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. This management strategy was utilized in the PAUSE study and was devised taking into account DOAC half-lives, manufacturer recommendations, and available literature. With this strategy, DOACs would be interrupted for three to four halflives, resulting in minimal residual anticoagulant effect. DOAC interruption is described by number of days rather than hours to allow for a simple pragmatic strategy that would be easy to apply in practice and follow by patients. This strategy was found to be safe and efficacious in the PAUSE and cardiac device insertion studies. This is the peri-procedural AC strategy for tunneled or port CVC insertion suggested by the ISTH. Receives: Other: Interrupted DOAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
proportion of eligible participants successfully recruited to the study and randomized to a treatment arm
Measured: 1 year
Secondary outcomes (6)
Eligibility rate
proportion of screened patients who are eligible
Measured: 1 year
Intervention adherence
proportion of recruited participants that adhere to the assigned study intervention
Measured: 1 year
DOAC level adherence
proportion of recruited participants that complete DOAC level testing
Measured: 1 year
Retention rate
proportion of recruited participants who attend the follow-up visit
Measured: 1 year
Study completion rate
proportion of recruited participants who completed all study procedures appropriately
Measured: 1 year
Reasons for declining participation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anticoagulant-induced BleedingStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Helliwell Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887270
- Sponsor's protocol ID
- 25-5249
- Acronym
- VENO CAT
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41722271
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06887270
- Acronym / sponsor ID
- VENO CAT / 25-5249
- Conditions
- Anticoagulant-induced Bleeding, Direct Oral Anticoagulant, Cancer, Central Venous Catheter, Periprocedural Complication
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Helliwell Foundation
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continued DOAC | Experimental | Other: Continued DOACThe continued DOAC group will continue their DOAC peri-procedurally as routine without interruption. This management strategy was devised based on the cardiac device insertion studies which found continued AC to be a safe and efficacious strategy for cardiac device insertion, which is procedurally similar to tunneled or port CVC insertion. This is the peri-procedural AC strategy for tunneled or port CVC insertion suggested by the Society of Interventional Radiology guidelines. |
| Interrupted DOAC | Active comparator | Other: Interrupted DOACThe 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. This management strategy was utilized in the PAUSE study and was devised taking into account DOAC half-lives, manufacturer recommendations, and available literature. With this strategy, DOACs would be interrupted for three to four halflives, resulting in minimal residual anticoagulant effect. DOAC interruption is described by number of days rather than hours to allow for a simple pragmatic strategy that would be easy to apply in practice and follow by patients. This strategy was found to be safe and efficacious in the PAUSE and cardiac device insertion studies. This is the peri-procedural AC strategy for tunneled or port CVC insertion suggested by the ISTH. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continued DOACThe continued DOAC group will continue their DOAC peri-procedurally as routine without interruption. | Other | Continued DOAC |
| Interrupted DOACThe 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. | Other | Interrupted DOAC |
Primary outcome
Recruitment rate
Time frame: 1 year
proportion of eligible participants successfully recruited to the study and randomized to a treatment arm
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Derived from this study: PubMed 41722271Abdulrehman 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.
- Individual participant dataSharing planned: No
Related trials for Anticoagulant-induced Bleeding
Enrolling by invitationPhase 4
LMWH vs Aspirin for VTE Prophylaxis in Orthopaedic Oncology
Sarcoma, Soft Tissue Sarcoma
Recruiting
Anticoagulation After GI Bleeding Pilot Study and Registry
GastroIntestinal Bleeding, Anticoagulant-induced Bleeding
RecruitingPhase 4
Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism
Pulmonary Embolism, Embolism
Active, not recruitingObservational study
Optimization of Management in Patients With Cardiovascular Disease After Lower Limb Joint Replacement
Thromboembolism, Anticoagulant-induced Bleeding
Not yet recruiting
FENOX Trial (Comparative Effectiveness of Fexuprazan Co-therapy in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulants)
Atrial Fibrillation (AF), Upper Gastrointestinal Bleeding (UGIB)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continued DOAC and Interrupted DOAC in people with Anticoagulant-induced Bleeding and Direct Oral Anticoagulant, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06887270, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.