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

NCT ID: NCT06383650

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2025-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

ASA 81mg

Daily study drug (x30 days)

Group Type: EXPERIMENTAL

Acetylsalicylic Acid

Intervention Type: 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

Daily study drug (x30 days)

Group Type: EXPERIMENTAL

Acetylsalicylic Acid

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

1. ≤18 years old

2. Known Pregnancy

3. Diagnosis of BCVI made based on imaging from another hospital (non-LTH)

4. Known pre-existing carotid/vertebral artery disease

5. Stroke on presentation/before BCVI diagnosis

6. Determined to require immediate surgical or interventional management of BCVI

7. Known allergy to ASA

8. Unable to consent OR absence of a Substitute Decision Maker (SDM)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western University

OTHER

Sponsor Role: collaborator

London Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Kelly Vogt

Medical Director, Trauma Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Kelly Vogt, MD

Role: CONTACT

kelly.vogt@lhsc.on.ca

619-685-8500 ext. 53075

Laura Allen, MSc

Role: CONTACT

lauraj.allen@lhsc.on.ca

519-685-8500 ext. 54459

Other Identifiers

124532

Identifier Type: -

Identifier Source: org_study_id