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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,000
intravenously administered Xingnaojing injection within 24 hours of symptom onset on ambulance or at hospital
Dongzhimen Hospital
Beijing, Beijing Municipality, China
RECRUITINGEarly neurological deterioration（change between baseline and 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).
Time frame: 3 days
Rate of stroke related deaths and deaths from any cause
Rate of stroke related deaths and deaths from any cause during hospitalization
Time frame: 14 days during hospitalization
Neurological impairment
Evaluated by National Institute of Health Stroke Scale (NIHSS)
Time frame: Baseline and day of discharge or 10 days
Risk grade of cerebral hemorrhage
Intracranial hemorrhage evaluated by Intracerebral Haemorrhage(ICH) scale.
Time frame: Baseline and day of discharge or 10 days
Activities of daily living
Activities of daily living will be measured by Barthel Index (BI)score at 30 days and 90 days.The Barthel Index score ranges from 0 (worst score) to 100 (best score).
Time frame: 30 days,60 days and 90 days
The proportion of patients independent
The proportion of patients independent will be evaluated by modified Rankin Scale(mRS).The mRS score ranges from 0 (best score) to 6 (worst score).
Time frame: 30 days,60 days and 90 days
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