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

June 9, 2020 updated by: Ying Gao, Dongzhimen Hospital, Beijing

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

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.

Study Overview

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Lingbo Kong, MD
  • Phone Number: 008613167323987
  • Email: klb1984@163.com

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100700
        • Recruiting
        • Dongzhimen Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

suspected acute stroke patient (call for emergency ambulance)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
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 )
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)
Incompletely unexposed group
xingnaojing injection will not be intravenously administered on ambulance but administered more than 24 hours of symptom onset at hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early neurological deterioration(change between baseline and 3 days)
Time Frame: 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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

February 7, 2020

First Submitted That Met QC Criteria

February 16, 2020

First Posted (Actual)

February 19, 2020

Study Record Updates

Last Update Posted (Actual)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 9, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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