Carotid Artery Injuries, Traumatic Injury, Vertebral Artery Injury
Conditions
Brief 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 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.
Interventions
DRUGAcetylsalicylic Acid
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.
Sponsors
Western University
London Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥ 18 years of age * Diagnosed with BCVI via CT angiography (CTA) within 72 hours of injury at a Level I Trauma Center
Exclusion criteria
1. ≤18 years old 2. Known Pregnancy 3. Diagnosis of BCVI made based on imaging from another hospital (non-LTH) 4. Known pre-existing carotid/vertebral artery disease 5. Stroke on presentation/before BCVI diagnosis 6. Determined to require immediate surgical or interventional management of BCVI 7. Known allergy to ASA 8. Unable to consent OR absence of a Substitute Decision Maker (SDM)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study feasibility | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of stroke | 30 days | The secondary objective will be evaluating the effectiveness of capturing strokes in the study participants during the study period. |
| Incidence of Bleeding Complications | 30 days | The secondary objective will be evaluating the effectiveness of capturing bleeding complications in the study participants during the study period. |
Contacts
Primary ContactKelly Vogt, MD
Backup ContactLaura Allen, MSc
Outcome results
None listed