Use of 81 vs 325mg of ASA in Treatment of BCVI | NCT06383650

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

NCT06383650

Sponsor

London Health Sciences Centre

Status

Unknown status

Last Update Posted

Apr 25, 2024Actual

Enrollment

40Estimated

Phase

Early Phase 1

Conditions

Carotid Artery Injuries
Traumatic Injury
Vertebral Artery Injury

Interventions

Acetylsalicylic Acid

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2024Estimated

Primary Completion Date

May 2025Estimated

Completion Date

Sep 2025Estimated

First Submitted Date

Mar 11, 2024

First Submission Date that Met QC Criteria

Apr 18, 2024

First Posted Date

Apr 25, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2024

Last Update Posted Date

Apr 25, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kelly Vogt, Medical Director, Trauma Program, London Health Sciences CentrePrincipal Investigator

Lead Sponsor

London Health Sciences CentreOTHER

Collaborators

Name	Class
Western University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ASA 81mg	Experimental	Daily study drug (x30 days)	Drug: Acetylsalicylic Acid
ASA 325mg	Experimental	Daily study drug (x30 days)	Drug: Acetylsalicylic Acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Incidence of stroke	The secondary objective will be evaluating the effectiveness of capturing strokes in the study participants during the study period.	30 days
Incidence of Bleeding Complications

Other Outcomes

Not provided

Eligibility Module

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:

≤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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kelly Vogt, MD	Contact	619-685-8500	53075	kelly.vogt@lhsc.on.ca
Laura Allen, MSc	Contact	519-685-8500	54459	lauraj.allen@lhsc.on.ca

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020212	Carotid Artery Injuries
D014947	Wounds and Injuries

Ancestor Terms

ID	Term
D002340	Carotid Artery Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001241	Aspirin

Ancestor Terms

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives

Browse Leaves

Not provided

Browse Branches

Not provided