- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04275349
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
Status
Unknown
Intervention / Treatment
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:
- Lingbo Kong, MD
- Phone Number: 0086-13167323987
- Email: klb1984@163.com
-
-
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.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ying Gao, MD, Dongzhimen Hospital, Beijing University of Chinese Medicine
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CFH 2018-1-4191
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.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
Clinical Trials on Xingnaojing injection within 24 hours of symptom onset
-
Jiang LiuRecruitingPostoperative Nausea and VomitingChina
-
Central Hospital, Nancy, FranceCompleted
-
Denver Health and Hospital AuthorityUniversity of Colorado, Denver; U.S. Army Medical Research and Development...Terminated
-
Sanliurfa Mehmet Akif Inan Education and Research...CompletedSecond Trimester Abortion | Uterocervical Angle | Cervical Consistency IndexTurkey
-
Assistance Publique - Hôpitaux de ParisCompletedHypoxic Ischemic EncephalopathyFrance
-
david andrewsCompletedNeoplasms | Malignant GliomaUnited States
-
Sichuan Provincial People's HospitalJiangsu Simcere Pharmaceutical Co., Ltd.Unknown
-
HTA Co., Ltd.Completed
-
Yale UniversityNational Heart, Lung, and Blood Institute (NHLBI)WithdrawnCoronary Artery Disease
-
Institut National de la Santé Et de la Recherche...Assistance Publique - Hôpitaux de Paris; Ministry of Health, France; Ministry...Terminated