Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05868525 | Recruiting | Blunt Cerebrovascular Injury

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

Condition or disease

Blunt Cerebrovascular Injury

Intervention/treatment

Aspirin 325Mg Tab, Aspirin 81Mg Tab

Phase

Phase 4

Study Type : Interventional
Estimated Enrollment : 98 participants
Masking : None (Open Label)
Primary Purpose : Prevention
Official 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).
Actual Study Start Date : April 2024
Estimated Primary Completion Date : April 1, 2025
Estimated Study Completion Date : August 1, 2025
Arm Intervention/treatment

Active Comparator: Oral Daily Aspirin 81 mg

Drug: Aspirin 325Mg Tab, Aspirin 81Mg Tab

Active Comparator: Oral Daily Aspirin 325 mg

Drug: Aspirin 325Mg Tab, Aspirin 81Mg Tab
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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
Stroke Rate in Patients With Blunt Cerebrovascular Injury (BCVI) Treated With Oral Acetylsalicylic Acid (ASA) 81 mg Versus ASA 325 mg (BASA).

Location Details

Please Choose a site

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

United States, California

Loma Linda University Medical Center

Loma Linda, California, United States, 92354