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 cerebrolysin, ambulance, mobile stroke unit, stroke
Conditions
Interventions
1. Erawan Center, Bangkok notifies the EMS Center, Chulalongkorn Hospital that a patient is suspected of having a symptomatic acute stroke within 3 hours
2. EMS Center, Chulalongkorn Hospital notifies
Stroke Treatment Unit, Phyathai 1 Hospital
3. Mobile CT &
Stroke Treatment Unit, Phyathai 1 Hospital and Advanced Life Support Ambulance, Chulalongkorn Hospital departs to the destination at the same time.
4. Arriving at the destination, the emergency medica
Stroke Treatment Unit, Phyathai 1 Hospital explains the information regarding benefits or side effects of clinical trial participation to the patient or relative and ask for consenting to participate
Stroke Treatment Unit at Phyathai 1 Hospital to classify the type of stroke.
8. Patients diagnosed with acute ischemic brain disease and no contraindications to intravenous thrombolysis will receive i
Stroke Treatment Unit.
9. Patients diagnosed with intracerebral hemorrhage will receive standard blood pressure control and other treatment.
10. Mobile CT &
Stroke Treatment Unit, Phyathai 1 Hospital transfer the patient to Chulalongkorn Hospital for further treatment.
11. Upon arrival at th
Active Comparator Drug,Active Comparator Drug
Mobile Stroke Unit (MSU),Emergency Medical Service (EMS)
Sponsors
Chulalongkorn Stroke Center
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion 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
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) 11. Concomitant treatment with substances that have a dilative effect on blood vessels like naftidrofuryl, or nimodipine 12. Patients which cannot tolerate or have contraindication to aspirin or Cerebrolysin treatment 13. Pregnancy and lactation period: 14. Participation in a clinical trial with an investigational drug in the past 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time interval from paramedic arrival on scene to start of study drug infusion 90 days Time | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients completing study treatment 90 days Percent | — |
Countries
Thailand
Contacts
Public ContactNijasri Suwanwela
Chulalongkorn University
Outcome results
None listed