TCTR20220310004
Unknown
Phase 2
Feasibility study of Cerebrolysin therapy in pre-hospital treatment of patients with acute stroke
Chulalongkorn Stroke Center0 sites20 target enrollmentMarch 10, 2022
ConditionsEarlier treatment after stroke onset improves long-term outcome. Pre-hospital treatment for stroke will be an important part of future stroke treatment. Early administration of neuroprotective agents could be beneficial for stroke patientscerebrolysin, ambulance, mobile stroke unit, stroke
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Earlier treatment after stroke onset improves long-term outcome. Pre-hospital treatment for stroke will be an important part of future stroke treatment. Early administration of neuroprotective agents could be beneficial for stroke patients
- Sponsor
- Chulalongkorn Stroke Center
- Enrollment
- 20
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients with clinical suspicion of acute stroke who were transferred to KCMH by KCMH ambulance or mobile stroke unit (MSU).
- •2\. Age 18\-85 years
- •3\. Onset of stroke or last seen well \< 3 hours prior to study entry
- •4\. NIHSS 6\-22
- •a. NIHSS \< 6 if patient has disabling stroke (up to investigator decision)
- •5\. Functionally independent prior to stroke with a pre\-stroke mRS of 0 or 1
- •6\. Informed consent was given by the patient and/or the patient's legally acceptable representative
Exclusion Criteria
- •1\. Unconsciousness
- •2\. Major surgery or severe trauma within past 14 days
- •3\. Recent stroke within past 30 day or gastrointestinal bleeing or urinary tract bleeding within past 21 days
- •4\. SBP \> 220 mmHg or DBP \> 120 mmHg on repeated measurement (interval of 10 min) prior to study entry
- •5\. Severe congestive heart failure or acute myocardial infarction within 3 months
- •6\. Risk of bleeding disorder, INR \> 1\.7
- •7\. Known history of epilepsy or seizures at onset of stroke
- •8\. History of severe coexisting systemic disease that significantly limits life expectancy (severe renal/liver impairment)
- •9\. Pre\-existing disorders or conditions that would impair interpretation of neurological assessment (e.g. severe dementia, severe psychiatric illnesses, etc.).
- •10\. Concomitant treatment with other neuroprotective or nootropic drugs (e.g. piracetam, citicoline, investigational neuroprotective substances)
Outcomes
Primary Outcomes
Not specified
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