NCT05868525招募中4 期
Pilot, Non-masked, Randomized Clinical Trial for Evaluation of Stroke Rate in Patients With Blunt Cerebrovascular Injury (BCVI) Treated With Oral Acetylsalicylic Acid (ASA) 81 mg Versus ASA 325 mg (BASA).
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Number of patients with new stroke event (ischemic stroke or hemorrhagic stroke)
研究概览
简要总结
The goal of this clinical trial is to compare difference between Aspirin 81 mg and Aspirin 325 mg in preventing strokes in patients with head and neck vessels injury.
The main questions it aims to answer are:
- If Aspirin 81 mg efficacy in prevention of stroke in patients with head and neck vessels injury is not lower than and Aspirin 325 mg.
- If rate of hemorrhagic complications in patients with head and neck vessels injury taking Aspirin 81 mg is not higher than patients that take Aspirin 325 mg.
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
- None
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
- •All patients with blunt cerebrovascular injury are diagnosed by computed tomography angiography (CTA) upon admission
排除标准
- •Pregnant women
- •No enteral route access for Aspirin administration
- •Patients who are on Heparin drip or other full dose anticoagulation when BCVI diagnosed
- •Patients who are on other Anti-Platelets aside from Aspirin when BCVI diagnosed
- •Patients with BCVI grade 5 injury based on Biffl classification
- •Presence of any contraindication or history of allergy to Aspirin
- •Patient with the diagnosis of acute stroke at the time of BCVI diagnosis matching the injured vessel territory on imaging
- •Patients with acute spinal trauma that needs surgical intervention
研究组 & 干预措施
Oral Daily Aspirin 81 mg
Active Comparator
干预措施: Aspirin 325Mg Tab, Aspirin 81Mg Tab (Drug)
Oral Daily Aspirin 325 mg
Active Comparator
干预措施: Aspirin 325Mg Tab, Aspirin 81Mg Tab (Drug)
结局指标
主要结局
Number of patients with new stroke event (ischemic stroke or hemorrhagic stroke)
时间窗: From randomization up to 3 months after discharge
次要结局
- Need for blood product transfusion(From randomization up to 30 day after randomization)
- Rate of any bleeding incidence(From randomization up to 30 day after randomization)
- Number of patients that experienced any incidence of worsening brain hemorrhage(From randomization up to 30 day after randomization)
- In-hospital mortality rate(From randomization up to 30 day after randomization)
- Number of patients that experienced any Aspirin-related adverse events(From randomization up to 3 months after discharge)
- Rate of need for bleeding control operations/interventions in patients with solid organ injury(From randomization up to 30 day after randomization)
- Change in severity of the neck and head vessels injury based on Biffl grading scale(From randomization up to 3 months after discharge)
- Out-patient mortality rate(From discharge up to 3 months after discharge)
- Any change in the percentage (%) of luminal stenosis in injured vessels of the neck and head(From randomization up to 3 months after discharge)
研究者
研究点 (1)
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