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Use of 81 vs 325mg of ASA in Treatment of BCVI

NCT06383650 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-04-25

No results posted yet for this study

Summary

Blunt cerebrovascular injury (BCVI), or injury to the carotid and vertebral arteries, occurs in 1-3% of blunt traumas, often as a result of injury to the head, neck, or chest. If unrecognized or untreated, BCVI can lead to stroke, which occurs in approximately 20% of untreated patients, potentially causing significant and sometimes permanent disability. Early diagnosis and treatment significantly reduce the risk of stroke.

Currently, there is wide variation across centers and trauma care providers in treatment strategies for BCVI and the most recent guidelines are unable to make specific recommendations about the optimal agent and/or dose of treatment to reduce the risk of stroke after BCVI while minimizing bleeding complications in patients with multiple traumatic injuries. Recent systematic reviews and meta-analyses evaluating the most common treatment strategies for BCVI have shown similar stroke rates with the use of anticoagulants (usually heparin) vs. antiplatelets (usually aspirin/ASA), however, treatment with antiplatelets was associated with a lower risk of bleeding complications. The optimal dose of ASA for stroke prevention while minimizing bleeding complications is unknown, and more research is required to inform future care.

This project will investigate two doses of antiplatelet therapy (81 mg daily vs. 325 mg daily aspirin) for BCVI treatment, and will look at the risk of stroke and bleeding complications with each strategy. The goal of the research is to determine whether a large-scale study looking at this question is feasible, which will ultimately help determine the best medical therapy for patients with BCVI.

Conditions

  • Carotid Artery Injuries
  • Traumatic Injury
  • Vertebral Artery Injury

Interventions

DRUG

Acetylsalicylic Acid

Patients will undergo CT imaging with the use of contrast for diagnosis of BCVI. Patients will be monitored for feasibility outcomes, as well as the development of stroke and bleeding complications.

Sponsors & Collaborators

  • Western University

    collaborator OTHER

  • London Health Sciences Centre

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2025-05-31
Completion
2025-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06383650 on ClinicalTrials.gov