Blunt Cerebrovascular Injury
Conditions
Keywords
Blunt cerebrovascular injury, BCVI, Carotid artery, Vertebral Artery, Internal Carotid Artery
Brief summary
The goal of this clinical trial is to compare difference between Aspirin 81 mg and Aspirin 325 mg in preventing strokes in patients with head and neck vessels injury. The main questions it aims to answer are: * If Aspirin 81 mg efficacy in prevention of stroke in patients with head and neck vessels injury is not lower than and Aspirin 325 mg. * If rate of hemorrhagic complications in patients with head and neck vessels injury taking Aspirin 81 mg is not higher than patients that take Aspirin 325 mg.
Interventions
DRUGAspirin 325Mg Tab, Aspirin 81Mg Tab
Patients will be administrated daily oral Aspirin 81 mg or oral Aspirin 325 mg according to their assigned group after randomization.
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 * All patients with blunt cerebrovascular injury are diagnosed by computed tomography angiography (CTA) upon admission
Exclusion criteria
* Age \<18 * Pregnant women * No enteral route access for Aspirin administration * Patients who are on Heparin drip or other full dose anticoagulation when BCVI diagnosed * Patients who are on other Anti-Platelets aside from Aspirin when BCVI diagnosed * Patients with BCVI grade 5 injury based on Biffl classification * Presence of any contraindication or history of allergy to Aspirin * Patient with the diagnosis of acute stroke at the time of BCVI diagnosis matching the injured vessel territory on imaging * Patients with acute spinal trauma that needs surgical intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with new stroke event (ischemic stroke or hemorrhagic stroke) | From randomization up to 3 months after discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients that experienced any Aspirin-related adverse events | From randomization up to 3 months after discharge | An allergic reaction or gastrointestinal bleeding |
| Rate of need for bleeding control operations/interventions in patients with solid organ injury | From randomization up to 30 day after randomization | — |
| Need for blood product transfusion | From randomization up to 30 day after randomization | — |
| Rate of any bleeding incidence | From randomization up to 30 day after randomization | major or minor bleeds define according to the International Society of Thrombosis and Hemostasis (ISTH) |
| Number of patients that experienced any incidence of worsening brain hemorrhage | From randomization up to 30 day after randomization | — |
| Any change in the percentage (%) of luminal stenosis in injured vessels of the neck and head | From randomization up to 3 months after discharge | — |
| Change in severity of the neck and head vessels injury based on Biffl grading scale | From randomization up to 3 months after discharge | — |
| In-hospital mortality rate | From randomization up to 30 day after randomization | — |
| Out-patient mortality rate | From discharge up to 3 months after discharge | — |
Countries
United States
Contacts
CONTACTMaryam B Tabrizi, M.D
CONTACTSina Asaadi, M.D
Outcome results
None listed