Trial of pRehospital Intervention With trAditional Chinese Medicine for Acute strokE

NCT ID: NCT04275349

Last Updated: 2020-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-20

Study Completion Date

2020-12-31

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.

Conditions

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Stroke Acute Ischemic Stroke Acute Intracranial Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

Xingnaojing injection within 24 hours of symptom onset

Intervention Type DRUG

intravenously administered Xingnaojing injection within 24 hours of symptom onset on ambulance or at hospital

Exposure group(uncontinuously)

xingnaojing injection will be intravenously administered within 24 hours of symptom onset for once (on prehospital ambulance )

Xingnaojing injection within 24 hours of symptom onset

Intervention Type DRUG

intravenously administered Xingnaojing injection within 24 hours of symptom onset on ambulance or at hospital

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)

No interventions assigned to this group

Incompletely unexposed group

xingnaojing injection will not be intravenously administered on ambulance but administered more than 24 hours of symptom onset at hospital

No interventions assigned to this group

Interventions

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Xingnaojing injection within 24 hours of symptom onset

intravenously administered Xingnaojing injection within 24 hours of symptom onset on ambulance or at hospital

Intervention Type DRUG

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)).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Emergency Medical Center

OTHER

Sponsor Role collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

Beijing Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Centre for Evidence Based Chinese Medicine, Beijing University of Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role collaborator

Beijing Shijitan Hospital, Capital Medical University

OTHER

Sponsor Role collaborator

Beijing Fengtai Youanmen Hospital

UNKNOWN

Sponsor Role collaborator

Beijing Jiangong Hospital

UNKNOWN

Sponsor Role collaborator

Beijing Chaoyang Emergency Medical Center

UNKNOWN

Sponsor Role collaborator

Beijing Chaoyang Integrative Medicine Emergency Medical Center

UNKNOWN

Sponsor Role collaborator

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role collaborator

Fangshan Hospital,Beijing University of Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Civil Aviation General Hospital

OTHER

Sponsor Role collaborator

The First Hospital of Fangshan District,Beijing

OTHER

Sponsor Role collaborator

Beijing Chinese Medicine Hospital-Pinggu Hospital

UNKNOWN

Sponsor Role collaborator

Beijing Pinggu District Hospital

OTHER

Sponsor Role collaborator

Dongzhimen Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Ying Gao

President of the Institute for Encephalopathy, Beijing University of Chinese Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ying Gao, MD

Role: PRINCIPAL_INVESTIGATOR

Dongzhimen Hospital, Beijing

Locations

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Dongzhimen Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ying Gao, MD

Role: CONTACT

0086-010-84013209

Lingbo Kong, MD

Role: CONTACT

008613167323987

Facility Contacts

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Ying Gao, MD

Role: primary

0086-010-84013209

Lingbo Kong, MD

Role: backup

0086-13167323987

References

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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.

Reference Type DERIVED
PMID: 36105230 (View on PubMed)

Other Identifiers

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CFH 2018-1-4191

Identifier Type: -

Identifier Source: org_study_id

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