Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06383650
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-03-11
Brief Title:
Use of 81 vs 325mg of ASA in Treatment of BCVI
Sponsor:
London Health Sciences Centre
Organization:
London Health Sciences Centre
Study Overview
Official Title:
Use of 81 vs 325mg of ASA in Treatment of BCVI A Feasibility RCT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 aspirinASA 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
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 andor 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 aspirinASA 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None