Carotid Artery InjuriesEarly Phase 1NCT06383650
Use of 81 vs 325mg of ASA in Treatment of BCVI
A Early Phase 1 study testing Acetylsalicylic Acid in people with Carotid Artery Injuries and Traumatic Injury, run by London Health Sciences Centre.
Trial summary
Blunt cerebrovascular injury (BCVI), or injury to the carotid and vertebral arteries, occurs in 1-3% of blunt traumas, often as a result of injury to the head, neck, or chest. If unrecognized or untreated, BCVI can lead to stroke, which occurs in approximately 20% of untreated patients, potentially causing significant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Injuries, Traumatic Injury, Vertebral Artery Injury
- What is being tested?
- Acetylsalicylic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Sep 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age
- Diagnosed with BCVI via CT angiography (CTA) within 72 hours of injury at a Level I Trauma Center
Who cannot join
- ≤18 years old
- Known Pregnancy
- Diagnosis of BCVI made based on imaging from another hospital (non-LTH)
- Known pre-existing carotid/vertebral artery disease
- Stroke on presentation/before BCVI diagnosis
- Determined to require immediate surgical or interventional management of BCVI
- Known allergy to ASA
- Unable to consent OR absence of a Substitute Decision Maker (SDM)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Use of 81 vs 325mg of ASA in Treatment of BCVI: A Feasibility RCT
Blunt cerebrovascular injury (BCVI), or injury to the carotid and vertebral arteries, occurs in 1-3% of blunt traumas, often as a result of injury to the head, neck, or chest. If unrecognized or untreated, BCVI can lead to stroke, which occurs in approximately 20% of untreated patients, potentially causing significant and sometimes permanent disability. Early diagnosis and treatment significantly reduce the risk of stroke.
Currently, there is wide variation across centers and trauma care providers in treatment strategies for BCVI and the most recent guidelines are unable to make specific recommendations about the optimal agent and/or dose of treatment to reduce the risk of stroke after BCVI while minimizing bleeding complications in patients with multiple traumatic injuries. Recent systematic reviews and meta-analyses evaluating the most common treatment strategies for BCVI have shown similar stroke rates with the use of anticoagulants (usually heparin) vs. antiplatelets (usually aspirin/ASA), however, treatment with antiplatelets was associated with a lower risk of bleeding complications. The optimal dose of ASA for stroke prevention while minimizing bleeding complications is unknown, and more research is required to inform future care.
This project will investigate two doses of antiplatelet therapy (81 mg daily vs. 325 mg daily aspirin) for BCVI treatment, and will look at the risk of stroke and bleeding complications with each strategy. The goal of the research is to determine whether a large-scale study looking at this question is feasible, which will ultimately help determine the best medical therapy for patients with BCVI.
- Being tested
- Acetylsalicylic Acid
- Medical subject headings
- Carotid Artery Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic AcidDrug
Patients will undergo CT imaging with the use of contrast for diagnosis of BCVI. Patients will be monitored for feasibility outcomes, as well as the development of stroke and bleeding complications.
| Study group | Role | What they receive |
|---|---|---|
| ASA 81mg | Experimental | Daily study drug (x30 days) Receives: Drug: Acetylsalicylic Acid |
| ASA 325mg | Experimental | Daily study drug (x30 days) Receives: Drug: Acetylsalicylic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study feasibility
The feasibility of the study and progression to pilot randomized controlled trial will be determined by whether it is possible to enroll ≥ 70% of eligible patients with BCVI within 90 minutes of diagnosis.
Measured: 1 year
Secondary outcomes (2)
Incidence of stroke
The secondary objective will be evaluating the effectiveness of capturing strokes in the study participants during the study period.
Measured: 30 days
Incidence of Bleeding Complications
The secondary objective will be evaluating the effectiveness of capturing bleeding complications in the study participants during the study period.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study startJun 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery InjuriesStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Western University
- Responsible party
- Principal investigator, Kelly Vogt, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383650
- Sponsor's protocol ID
- 124532
- Status last verified
- Apr 2024
- First submitted
- 11 Mar 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of 81 vs 325mg of ASA in Treatment of BCVI: A Feasibility RCT
- ClinicalTrials.gov ID
- NCT06383650
- Acronym / sponsor ID
- 124532
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- London Health Sciences CentreUniversity, hospital or other
- Collaborators
- Western University
- Study start
- Jun 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 25 Apr 2024 (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.
Blunt cerebrovascular injury (BCVI), or injury to the carotid and vertebral arteries, occurs in 1-3% of blunt traumas, often as a result of injury to the head, neck, or chest. If unrecognized or untreated, BCVI can lead to stroke, which occurs in approximately 20% of untreated patients, potentially causing significant and sometimes permanent disability. Early diagnosis and treatment significantly reduce the risk of stroke.
Currently, there is wide variation across centers and trauma care providers in treatment strategies for BCVI and the most recent guidelines are unable to make specific recommendations about the optimal agent and/or dose of treatment to reduce the risk of stroke after BCVI while minimizing bleeding complications in patients with multiple traumatic injuries. Recent systematic reviews and meta-analyses evaluating the most common treatment strategies for BCVI have shown similar stroke rates with the use of anticoagulants (usually heparin) vs. antiplatelets (usually aspirin/ASA), however, treatment with antiplatelets was associated with a lower risk of bleeding complications. The optimal dose of ASA for stroke prevention while minimizing bleeding complications is unknown, and more research is required to inform future care.
This project will investigate two doses of antiplatelet therapy (81 mg daily vs. 325 mg daily aspirin) for BCVI treatment, and will look at the risk of stroke and bleeding complications with each strategy. The goal of the research is to determine whether a large-scale study looking at this question is feasible, which will ultimately help determine the best medical therapy for patients with BCVI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASA 81mg | Experimental | Drug: Acetylsalicylic AcidDaily study drug (x30 days) |
| ASA 325mg | Experimental | Drug: Acetylsalicylic AcidDaily study drug (x30 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients ≥ 18 years of age
- Diagnosed with BCVI via CT angiography (CTA) within 72 hours of injury at a Level I Trauma Center
Key exclusion criteria (8 listed)
- ≤18 years old
- Known Pregnancy
- Diagnosis of BCVI made based on imaging from another hospital (non-LTH)
- Known pre-existing carotid/vertebral artery disease
- Stroke on presentation/before BCVI diagnosis
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 |
|---|---|---|
| Acetylsalicylic AcidPatients will undergo CT imaging with the use of contrast for diagnosis of BCVI. Patients will be monitored for feasibility outcomes, as well as the development of stroke and bleeding complications. | Drug | ASA 325mg, ASA 81mg |
Primary outcome
Study feasibility
Time frame: 1 year
The feasibility of the study and progression to pilot randomized controlled trial will be determined by whether it is possible to enroll ≥ 70% of eligible patients with BCVI within 90 minutes of diagnosis.
2 secondary outcomes
Incidence of stroke
Time frame: 30 days
Incidence of Bleeding Complications
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Acetylsalicylic Acid in people with Carotid Artery Injuries and Traumatic Injury, run by London Health Sciences Centre.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kelly Vogt, MD (619-685-8500 ext. 53075, kelly.vogt@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study feasibility (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2024.