Feasibility study of Cerebrolysin therapy in pre-hospital treatment of patients with acute stroke

Chulalongkorn Stroke Center0 个研究点目标入组 20 人开始时间: 2022年3月10日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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

•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

发起方

Chulalongkorn Stroke Center