Trial of pRehospital Intervention With trAditional Chinese Medicine for Acute strokE

• Conditions: Acute Intracranial Hemorrhage; Stroke; Acute Ischemic Stroke
• Interventions: Drug: Xingnaojing injection within 24 hours of symptom onset

• Registration Number: NCT04275349
• Lead Sponsor: Dongzhimen Hospital, Beijing

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 Timeline

• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-02-16
• Study First Posted: 2020-02-19
• Study Start: 2020-03-20
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-09
• Last Update Posted: 2020-06-11
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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)).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposure group(uncontinuously)	Xingnaojing injection within 24 hours of symptom onset	xingnaojing injection will be intravenously administered within 24 hours of symptom onset for once (on prehospital ambulance )
Exposure group(continuously)	Xingnaojing injection within 24 hours of symptom onset	xingnaojing injection will be intravenously administered within 24 hours of symptom onset until to third day (from prehospital ambulance to hospital or at hospital)

Primary Outcome Measures

Name	Time	Method
Early neurological deterioration（change between baseline and 3 days)	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 Outcome Measures

Name	Time	Method
Risk grade of cerebral hemorrhage	Baseline and day of discharge or 10 days	Intracranial hemorrhage evaluated by Intracerebral Haemorrhage(ICH) scale.
The proportion of patients independent	30 days,60 days and 90 days	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).
Rate of stroke related deaths and deaths from any cause	14 days during hospitalization	Rate of stroke related deaths and deaths from any cause during hospitalization
Activities of daily living	30 days,60 days and 90 days	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).
Neurological impairment	Baseline and day of discharge or 10 days	Evaluated by National Institute of Health Stroke Scale (NIHSS)

Trial Locations

Locations (1)

Dongzhimen Hospital; 🇨🇳 Beijing, Beijing, China