Trial of pRehospital Intervention With trAditional Chinese Medicine for Acute strokE: A Mixed Methods Research
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Early neurological deterioration（change between baseline and 3 days)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)).
Arms & Interventions
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)
Intervention: 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 )
Intervention: Xingnaojing injection within 24 hours of symptom onset (Drug)
Outcomes
Primary Outcomes
Early neurological deterioration（change between baseline and 3 days)
Time Frame: 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).
Secondary Outcomes
- 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)
Investigators
Ying Gao
President of the Institute for Encephalopathy, Beijing University of Chinese Medicine
Dongzhimen Hospital, Beijing