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

Phase 2

• 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; cerebrolysin, ambulance, mobile stroke unit, stroke

• Registration Number: TCTR20220310004
• Lead Sponsor: Chulalongkorn Stroke Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-10
• Study Completion: 2023-05-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: nknown
• Sex: All
• Target Recruitment: 20

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)
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time interval from paramedic arrival on scene to start of study drug infusion 90 days Time

Secondary Outcome Measures

Name	Time	Method
Proportion of patients completing study treatment 90 days Percent