Trial of pRehospital Intervention With trAditional Chinese Medicine for Acute strokE

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Trial of pRehospital Intervention With trAditional Chinese Medicine for Acute strokE: A Mixed Methods Research

Conditions
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Stroke, Acute Ischemic Stroke, Acute Intracranial Hemorrhage

Intervention / Treatment
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* Drug: Xingnaojing injection within 24 hours of symptom onset


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of suspected acute stroke； Symptom onset within 24 hours； Age ≥ 18 . Exclusion Criteria: 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)).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposure group(continuously)<br>xingnaojing injection will be intravenously administered within 24 hours of symptom onset until to third day (from prehospital ambulance to hospital or at hospital) | Drug: Xingnaojing injection within 24 hours of symptom onset<br>* intravenously administered Xingnaojing injection within 24 hours of symptom onset on ambulance or at hospital<br>|
| Exposure group(uncontinuously)<br>xingnaojing injection will be intravenously administered within 24 hours of symptom onset for once (on prehospital ambulance ) | Drug: Xingnaojing injection within 24 hours of symptom onset<br>* intravenously administered Xingnaojing injection within 24 hours of symptom onset on ambulance or at hospital<br>|
| Completely unexposed group<br>xingnaojing injection will not be intravenously administered within 24 hours of symptom onset until to third day (from prehospital ambulance to hospital) | |
| Incompletely unexposed group<br>xingnaojing injection will not be intravenously administered on ambulance but administered more than 24 hours of symptom onset at hospital | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early 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). | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of stroke related deaths and deaths from any cause | Rate of stroke related deaths and deaths from any cause during hospitalization | 14 days during hospitalization | 
| Neurological impairment | Evaluated by National Institute of Health Stroke Scale (NIHSS) | Baseline and day of discharge or 10 days | 
| Risk grade of cerebral hemorrhage | Intracranial hemorrhage evaluated by Intracerebral Haemorrhage(ICH) scale. | 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). | 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). | 30 days,60 days and 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Registry, Cohort study, Mixed methods, Prehospital, Stroke