Use of 81 vs 325mg of ASA in Treatment of BCVI: A Feasibility RCT
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Study feasibility
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years of age
- •Diagnosed with BCVI via CT angiography (CTA) within 72 hours of injury at a Level I Trauma Center
排除标准
- •≤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)
研究组 & 干预措施
ASA 325mg
Daily study drug (x30 days)
干预措施: Acetylsalicylic Acid (Drug)
ASA 81mg
Daily study drug (x30 days)
干预措施: Acetylsalicylic Acid (Drug)
结局指标
主要结局
Study feasibility
时间窗: 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.
次要结局
- Incidence of stroke(30 days)
- Incidence of Bleeding Complications(30 days)
研究者
Kelly Vogt
Medical Director, Trauma Program
London Health Sciences Centre