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| Name | Class |
|---|---|
| Beijing Emergency Medical Center | OTHER |
| Beijing Tiantan Hospital | OTHER |
| Beijing Hospital of Traditional Chinese Medicine | OTHER |
| Centre for Evidence Based Chinese Medicine, Beijing University of Chinese Medicine |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
| |
| Exposure group(uncontinuously) | xingnaojing injection will be intravenously administered within 24 hours of symptom onset for once (on prehospital ambulance ) |
| |
| Completely unexposed group | 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 | xingnaojing injection will not be intravenously administered on ambulance but administered more than 24 hours of symptom onset at hospital |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xingnaojing injection within 24 hours of symptom onset | Drug | intravenously administered Xingnaojing injection within 24 hours of symptom onset on ambulance or at hospital |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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suspected acute stroke patient (call for emergency ambulance)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Gao, MD | Contact | 0086-010-84013209 | gaoying973@126.com | |
| Lingbo Kong, MD | Contact | 008613167323987 | klb1984@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying Gao, MD | Dongzhimen Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongzhimen Hospital | Recruiting | Beijing | Beijing Municipality | 100700 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36105230 | Derived | Chen Y, Tian Z, Wang S, Liu H, Liu Y, Peng W, Lai X, Qi D, Kong L, Gao Y. Trial of a prehospital intervention with traditional Chinese medicine for acute stroke (TRACE): Protocol for a mixed-methods research study. Front Pharmacol. 2022 Aug 29;13:879282. doi: 10.3389/fphar.2022.879282. eCollection 2022. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| UNKNOWN |
| Xuanwu Hospital, Beijing | OTHER |
| Beijing Friendship Hospital | OTHER |
| Beijing Chao Yang Hospital | OTHER |
| Beijing Shijitan Hospital, Capital Medical University | OTHER |
| Beijing Fengtai Youanmen Hospital | UNKNOWN |
| Beijing Jiangong Hospital | UNKNOWN |
| Beijing Chaoyang Emergency Medical Center | UNKNOWN |
| Beijing Chaoyang Integrative Medicine Emergency Medical Center | UNKNOWN |
| Guang'anmen Hospital of China Academy of Chinese Medical Sciences | OTHER |
| Fangshan Hospital，Beijing University of Chinese Medicine | UNKNOWN |
| Civil Aviation General Hospital | OTHER |
| The First Hospital of Fangshan District,Beijing | OTHER |
| Beijing Chinese Medicine Hospital-Pinggu Hospital | UNKNOWN |
| Beijing Pinggu District Hospital | OTHER |
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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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |