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

NCT06383650 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 124532
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Study feasibility

  The feasibility of the study and progression to pilot randomized controlled trial will be determined by whether it is possible to enroll ≥ 70% of eligible patients with BCVI within 90 minutes of diagnosis.

  1 year

Secondary Outcomes (2)

• Incidence of stroke

  30 days

• Incidence of Bleeding Complications

  30 days

Study Arms (2)

ASA 81mg

EXPERIMENTAL

Daily study drug (x30 days)

Drug: Acetylsalicylic Acid

ASA 325mg

EXPERIMENTAL

Daily study drug (x30 days)

Drug: Acetylsalicylic Acid

Interventions

Acetylsalicylic Acid DRUG

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.

ASA 325mg; ASA 81mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years of age
• Diagnosed with BCVI via CT angiography (CTA) within 72 hours of injury at a Level I Trauma Center

You may not qualify if:

• ≤18 years old
• Known Pregnancy
• Diagnosis of BCVI made based on imaging from another hospital (non-LTH)
• Known pre-existing carotid/vertebral artery disease
• Stroke on presentation/before BCVI diagnosis
• Determined to require immediate surgical or interventional management of BCVI
• Known allergy to ASA
• Unable to consent OR absence of a Substitute Decision Maker (SDM)

Sponsors & Collaborators

• London Health Sciences Centre: lead
• Western University: collaborator

MeSH Terms

Conditions

Carotid Artery Injuries; Wounds and Injuries

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Kelly Vogt, MD

CONTACT

619-685-8500; kelly.vogt@lhsc.on.ca

Laura Allen, MSc

CONTACT

519-685-8500; lauraj.allen@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Trauma Program

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: April 25, 2024
• Study Start: June 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 25, 2024

Record last verified: 2024-04