Trial of pRehospital Intervention With trAditional Chinese Medicine for Acute strokE: A Mixed Methods Research
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Early neurological deterioration（change between baseline and 3 days)
研究概览
简要总结
The main purpose of this trial is to observe whether Xingnaojing, intravenously administered within 24 hours of symptom onset on pre-hospital emergency ambulance, improves the Early neurological deterioration of acute stroke at 3 days.
详细描述
The TRACE is a multicenter, registry observational study. Xingnaojing injection is the only essential traditional chinese medicine on emergency ambulance used for acute stroke.The primary hypothesis of this trial is that Xingnaojing used for acute stroke within 24 hours of symptom onset on ambulance will improve the Early neurological deterioration of acute stroke at 3 days. All suspected acute stroke participants will be registered once they are taken on the ambulance. The primary outcome will be determined at 3 days.Besides, there will be a quantitative interview with emergency doctors about their knowledge and attitude on Xingnaojing for acute stroke patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosis of suspected acute stroke；
- •Symptom onset within 24 hours；
- •Age ≥ 18 .
排除标准
- •Other conditions that lead to motor dysfunction (e.g., severe osteoarthrosis, rheumatoid arthritis);
- •Other conditions that render outcomes or follow-up unlikely to be assessed; Known to be pregnant or breastfeeding;
- •Non-acute stroke (result from Computed Tomography(CT) or Magnetic Resonance Imaging(MRI)).
研究组 & 干预措施
Exposure group(continuously)
xingnaojing injection will be intravenously administered within 24 hours of symptom onset until to third day (from prehospital ambulance to hospital or at hospital)
干预措施: Xingnaojing injection within 24 hours of symptom onset (Drug)
Exposure group(uncontinuously)
xingnaojing injection will be intravenously administered within 24 hours of symptom onset for once (on prehospital ambulance )
干预措施: Xingnaojing injection within 24 hours of symptom onset (Drug)
结局指标
主要结局
Early neurological deterioration（change between baseline and 3 days)
时间窗: 3 days
The early neurologic deterioration is defined as an increase of 1 points or more in the National Institute of Health Stroke Scale (NIHSS) score between baseline and 3 days. The NIHSS score ranges from 0 (best score) to 42 (worst score).
次要结局
- Risk grade of cerebral hemorrhage(Baseline and day of discharge or 10 days)
- The proportion of patients independent(30 days,60 days and 90 days)
- Rate of stroke related deaths and deaths from any cause(14 days during hospitalization)
- Activities of daily living(30 days,60 days and 90 days)
- Neurological impairment(Baseline and day of discharge or 10 days)
研究者
Ying Gao
President of the Institute for Encephalopathy, Beijing University of Chinese Medicine
Dongzhimen Hospital, Beijing