Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Location status: Recruiting
Recruiting
NCT Number: NCT05868525
Stroke Rate in Patients With Blunt Cerebrovascular Injury (BCVI) Treated With Oral Acetylsalicylic Acid (ASA) 81 mg Versus ASA 325 mg (BASA).
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Aspirin 325Mg Tab, Aspirin 81Mg Tab
DrugPatients will be administrated daily oral Aspirin 81 mg or oral Aspirin 325 mg according to their assigned group after randomization.
Primary outcomes
-
Number of patients with new stroke event (ischemic stroke or hemorrhagic stroke)
Time frame: From randomization up to 3 months after discharge
Secondary outcomes
-
Number of patients that experienced any Aspirin-related adverse events
Time frame: 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
Time frame: From randomization up to 30 day after randomization
-
Need for blood product transfusion
Time frame: From randomization up to 30 day after randomization
-
Rate of any bleeding incidence
Time frame: 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
Time frame: From randomization up to 30 day after randomization
-
Any change in the percentage (%) of luminal stenosis in injured vessels of the neck and head
Time frame: From randomization up to 3 months after discharge
-
Change in severity of the neck and head vessels injury based on Biffl grading scale
Time frame: From randomization up to 3 months after discharge
-
In-hospital mortality rate
Time frame: From randomization up to 30 day after randomization
-
Out-patient mortality rate
Time frame: From discharge up to 3 months after discharge
Study contacts
Contact information is provided by the study sponsor or research team.
Maryam B Tabrizi, M.D
CONTACT
Sina Asaadi, M.D
CONTACT
Sponsors and collaborators
Lead sponsor
Loma Linda University
Other
Registry information
Official study title
Pilot, Non-masked, Randomized Clinical Trial for Evaluation of Stroke Rate in Patients With Blunt Cerebrovascular Injury (BCVI) Treated With Oral Acetylsalicylic Acid (ASA) 81 mg Versus ASA 325 mg (BASA).
Acronym: BASA
Important dates
- Study start
- 2023
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- May 22, 2023
- Registry last updated
- Jan 30, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.