Trial of pRehospital Intervention With trAditional Chinese Medicine for Acute strokE
TRACE
1 other identifier
observational
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2020
CompletedFirst Posted
Study publicly available on registry
February 19, 2020
CompletedStudy Start
First participant enrolled
March 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJune 11, 2020
June 1, 2020
9 months
February 7, 2020
June 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Rate of stroke related deaths and deaths from any cause
14 days during hospitalization
Neurological impairment
Baseline and day of discharge or 10 days
Risk grade of cerebral hemorrhage
Baseline and day of discharge or 10 days
Activities of daily living
30 days,60 days and 90 days
The proportion of patients independent
30 days,60 days and 90 days
Study Arms (4)
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
Interventions
intravenously administered Xingnaojing injection within 24 hours of symptom onset on ambulance or at hospital
Eligibility Criteria
suspected acute stroke patient (call for emergency ambulance)
You may qualify if:
- Diagnosis of suspected acute stroke；
- Symptom onset within 24 hours；
- Age ≥ 18 .
You may not qualify if:
- 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)).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dongzhimen Hospital, Beijinglead
- Beijing Emergency Medical Centercollaborator
- Beijing Tiantan Hospitalcollaborator
- Beijing Hospital of Traditional Chinese Medicinecollaborator
- Centre for Evidence Based Chinese Medicine, Beijing University of Chinese Medicinecollaborator
- Xuanwu Hospital, Beijingcollaborator
- Beijing Friendship Hospitalcollaborator
- Beijing Chao Yang Hospitalcollaborator
- Beijing Shijitan Hospital, Capital Medical Universitycollaborator
- Beijing Fengtai Youanmen Hospitalcollaborator
- Beijing Jiangong Hospitalcollaborator
- Beijing Chaoyang Emergency Medical Centercollaborator
- Beijing Chaoyang Integrative Medicine Emergency Medical Centercollaborator
- Guang'anmen Hospital of China Academy of Chinese Medical Sciencescollaborator
- Fangshan Hospital，Beijing University of Chinese Medicinecollaborator
- Civil Aviation General Hospitalcollaborator
- The First Hospital of Fangshan District,Beijingcollaborator
- Beijing Chinese Medicine Hospital-Pinggu Hospitalcollaborator
- Beijing Pinggu District Hospitalcollaborator
Study Sites (1)
Dongzhimen Hospital
Beijing, Beijing Municipality, 100700, China
Related Publications (1)
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.
PMID: 36105230DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ying Gao, MD
Dongzhimen Hospital, Beijing
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- President of the Institute for Encephalopathy, Beijing University of Chinese Medicine
Study Record Dates
First Submitted
February 7, 2020
First Posted
February 19, 2020
Study Start
March 20, 2020
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
June 11, 2020
Record last verified: 2020-06