Stroke Rate in Patients With Blunt Cerebrovascular Injury (BCVI) Treated With Oral Acetylsalicylic Acid (ASA) 81 mg Versus ASA 325 mg (BASA).

Study Overview
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Brief Summary
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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.

Official Title
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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).

Conditions
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Blunt Cerebrovascular Injury

Intervention / Treatment
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* Drug: Aspirin 325Mg Tab, Aspirin 81Mg Tab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral Daily Aspirin 81 mg<br> | Drug: Aspirin 325Mg Tab, Aspirin 81Mg Tab<br>* Patients will be administrated daily oral Aspirin 81 mg or oral Aspirin 325 mg according to their assigned group after randomization.<br>|
| Active Comparator: Oral Daily Aspirin 325 mg<br> | Drug: Aspirin 325Mg Tab, Aspirin 81Mg Tab<br>* Patients will be administrated daily oral Aspirin 81 mg or oral Aspirin 325 mg according to their assigned group after randomization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with new stroke event (ischemic stroke or hemorrhagic stroke) |  | From randomization up to 3 months after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients that experienced any Aspirin-related adverse events | An allergic reaction or gastrointestinal bleeding | From randomization up to 3 months after discharge | 
| 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 | major or minor bleeds define according to the International Society of Thrombosis and Hemostasis (ISTH) | From randomization up to 30 day after randomization | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blunt cerebrovascular injury, BCVI, Carotid artery, Vertebral Artery, Internal Carotid Artery