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

Early Phase 1

Not yet recruiting

• Conditions: Carotid Artery Injuries; Traumatic Injury; Vertebral Artery Injury
• Interventions: Drug: Acetylsalicylic Acid

• Registration Number: NCT06383650
• Lead Sponsor: London Health Sciences Centre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-11
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-18
• Last Update Submitted: 2024-04-18
• Study First Posted: 2024-04-25
• Last Update Posted: 2024-04-25
• Study Start: 2024-06
• Primary Completion: 2025-05
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASA 325mg	Acetylsalicylic Acid	Daily study drug (x30 days)
ASA 81mg	Acetylsalicylic Acid	Daily study drug (x30 days)

Primary Outcome Measures

Name	Time	Method
Study feasibility	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of stroke	30 days	The secondary objective will be evaluating the effectiveness of capturing strokes in the study participants during the study period.
Incidence of Bleeding Complications	30 days	The secondary objective will be evaluating the effectiveness of capturing bleeding complications in the study participants during the study period.