Trial of pRehospital Intervention With trAditional Chinese Medicine for Acute strokE (TRACE)

Dongzhimen Hospital, Beijing

Status: Unknown

Conditions: Stroke; Acute Intracranial Hemorrhage; Acute Ischemic Stroke

Treatments: Drug: Xingnaojing injection within 24 hours of symptom onset

Study type: Observational

Funder types: Other

Identifiers

NCT04275349

CFH 2018-1-4191

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)).

Trial design

1,000 participants in 4 patient groups

Exposure group(continuously)

Description:

xingnaojing injection will be intravenously administered within 24 hours of symptom onset until to third day (from prehospital ambulance to hospital or at hospital)

Treatment:

Drug: Xingnaojing injection within 24 hours of symptom onset

Exposure group(uncontinuously)

Description:

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

Treatment:

Drug: Xingnaojing injection within 24 hours of symptom onset

Completely unexposed group

Description:

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

Description:

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