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

Phase 4

Recruiting

• Conditions: Blunt Cerebrovascular Injury
• Interventions: Drug: Aspirin 325Mg Tab, Aspirin 81Mg Tab

• Registration Number: NCT05868525
• Lead Sponsor: Loma Linda University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-01
• Study First Submitted QC: 2023-05-18
• Study First Posted: 2023-05-22
• Study Start: 2023-08-23
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-15
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Daily Aspirin 81 mg	Aspirin 325Mg Tab, Aspirin 81Mg Tab	-
Oral Daily Aspirin 325 mg	Aspirin 325Mg Tab, Aspirin 81Mg Tab	-

Primary Outcome Measures

Name	Time	Method
Number of patients with new stroke event (ischemic stroke or hemorrhagic stroke)	From randomization up to 3 months after discharge

Secondary Outcome Measures

Name	Time	Method
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
In-hospital mortality rate	From randomization up to 30 day after randomization
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
Change in severity of the neck and head vessels injury based on Biffl grading scale	From randomization up to 3 months after discharge
Out-patient mortality rate	From discharge up to 3 months after discharge
Need for blood product transfusion	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

Trial Locations

Locations (1)

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States