Clinical trial NCT04275349: Trial of pRehospital Intervention With trAditional Chinese Medicine for Acute strokE
Official title: Trial of pRehospital Intervention With trAditional Chinese Medicine for Acute strokE: A Mixed Methods Research
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Acute Ischemic Stroke
Acute Intracranial Hemorrhage
Keywords: Registry
Cohort study
Mixed methods
Prehospital
Stroke
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Beijing Emergency Medical Center
name: Beijing Tiantan Hospital
name: Beijing Hospital of Traditional Chinese Medicine
name: Centre for Evidence Based Chinese Medicine, Beijing University of Chinese Medicine
name: Xuanwu Hospital, Beijing
name: Beijing Friendship Hospital
name: Beijing Chao Yang Hospital
name: Beijing Shijitan Hospital, Capital Medical University
name: Beijing Fengtai Youanmen Hospital
name: Beijing Jiangong Hospital
name: Beijing Chaoyang Emergency Medical Center
name: Beijing Chaoyang Integrative Medicine Emergency Medical Center
name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Fangshan Hospital，Beijing University of Chinese Medicine
name: Civil Aviation General Hospital
name: The First Hospital of Fangshan District,Beijing
name: Beijing Chinese Medicine Hospital-Pinggu Hospital
name: Beijing Pinggu District Hospital
First posted: 2020-02-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: suspected acute stroke patient (call for emergency ambulance)

Brief summary: 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: 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.

Eligibility criteria: 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)).

Primary outcomes:
measure: Early neurological deterioration（change between baseline and 3 days)
timeFrame: 3 days
Secondary outcomes:
measure: Rate of stroke related deaths and deaths from any cause
timeFrame: 14 days during hospitalization
measure: Neurological impairment
timeFrame: Baseline and day of discharge or 10 days
measure: Risk grade of cerebral hemorrhage
timeFrame: Baseline and day of discharge or 10 days
measure: Activities of daily living
timeFrame: 30 days,60 days and 90 days
measure: The proportion of patients independent
timeFrame: 30 days,60 days and 90 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital
state: Beijing
Study officials:
affiliation: Dongzhimen Hospital, Beijing
name: Ying Gao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.