Trial of pRehospital Intervention With trAditional Chinese Medicine for Acute strokE

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04275349

Acronym

TRACE

Enrollment

1000

Registered

2020-02-19

Start date

2020-03-20

Completion date

2020-12-31

Last updated

2020-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Intracranial Hemorrhage, Acute Ischemic Stroke, Stroke

Keywords

Registry, Cohort study, Mixed methods, Prehospital, Stroke

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.

Interventions

DRUGXingnaojing injection within 24 hours of symptom onset

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)).

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

China

Contacts

Primary ContactYing Gao, MD

gaoying973@126.com0086-010-84013209

Backup ContactLingbo Kong, MD

klb1984@163.com008613167323987

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 14, 2026