Trial of pRehospital Intervention With trAditional Chinese Medicine for Acute strokE

Stroke Clinical Trial

— TRACE  

Official title:

Trial of pRehospital Intervention With trAditional Chinese Medicine for Acute strokE: A Mixed Methods Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04275349
• Other study ID #: CFH 2018-1-4191
• Status: Recruiting
• Start date: March 20, 2020
• Est. completion date: December 2020

Study information

• Verified date: June 2020
• Source: Dongzhimen Hospital, Beijing
• Contact: Ying Gao, MD
• Phone: 0086-010-84013209
• Email: gaoying973[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)).

Related Conditions & MeSH terms

• Acute Intracranial Hemorrhage
• Acute Ischemic Stroke
• Hemorrhage
• Intracranial Hemorrhages
• Stroke

Intervention

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

Locations

Country	Name	City	State
China	Dongzhimen Hospital	Beijing	Beijing

Sponsors (19)

Lead Sponsor

Collaborator

Dongzhimen Hospital, Beijing

Beijing Chao Yang Hospital, Beijing Chaoyang Emergency Medical Center, Beijing Chaoyang Integrative Medicine Emergency Medical Center, Beijing Chinese Medicine Hospital-Pinggu Hospital, Beijing Emergency Medical Center, Beijing Fengtai Youanmen Hospital, Beijing Friendship Hospital, Beijing Hospital of Traditional Chinese Medicine, Beijing Jiangong Hospital, Beijing Pinggu District Hospital, Beijing Shijitan Hospital,Capital Medical University, Beijing Tiantan Hospital, Centre for Evidence Based Chinese Medicine, Beijing University of Chinese Medicine, Civil Aviation General Hospital, Fangshan Hospital,Beijing University of Chinese Medicine, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, The First Hospital of Fangshan District,Beijing, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Neurological impairment	Evaluated by National Institute of Health Stroke Scale (NIHSS)	Baseline and day of discharge or 10 days
Secondary	Risk grade of cerebral hemorrhage	Intracranial hemorrhage evaluated by Intracerebral Haemorrhage(ICH) scale.	Baseline and day of discharge or 10 days
Secondary	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
Secondary	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