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

Traumatic Injury Clinical Trial

Official title:

Use of 81 vs 325mg of ASA in Treatment of BCVI: A Feasibility RCT

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06383650
• Other study ID #: 124532
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 2024
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: London Health Sciences Centre
• Contact: Kelly Vogt, MD
• Phone: 619-685-8500
• Email: kelly.vogt[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carotid Artery Injuries
• Traumatic Injury
• Vertebral Artery Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
London Health Sciences Centre	Western University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of stroke	The secondary objective will be evaluating the effectiveness of capturing strokes in the study participants during the study period.	30 days
Secondary	Incidence of Bleeding Complications	The secondary objective will be evaluating the effectiveness of capturing bleeding complications in the study participants during the study period.	30 days