This study is designed to determine the safety and feasibility of using Cerebrolysin in treating primary intracerebral hemorrhage (ICH). This is a multicenter, prospective, randomized, open-label, blinded end-point, phase IV parallel group study done in specialized stroke treatment centers in Poland. The study objective is to evaluate if a 14-day cerebrolysin treatment initiated within 6 hours of onset of primary lobar hemorrhage in addition to the standard of care that includes early intensive rehabilitation is safe and feasible, affects hematoma growth and improves the outcome. This study is designed to assess the early effect of using Cerebrolysin in patients after ICH, therefore 3 months of follow-up has been chosen. Patients will receive 50 ml of Cerebrolysin once daily until day 14. Subjects will be evaluated on Day 1 (baseline), Day 2, Day 7, Day 30 and Day 90. Enrollment to the study is expected to reach 30 subjects in 12 months. The study should be completed within 15 months (the end of study). The primary outcome measure will be change from baseline in functional independence (mRS 0-2) at Day 90 following stroke onset. The safety outcome will be the number of serious adverse events until Day 30.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
14-day cerebrolysin treatment initiated within 6 hours of onset of stroke
Standard of care treatment
Efficacy Outcome
Change from baseline in functional independence (mRS 0-2) at Day 90 following stroke onset
Time frame: 90 days from stroke onset
Safety Outcome
Number of Serious Adverse Events until Day 30
Time frame: 30 days from stroke onset
Neurological deficit
Change from baseline in neurological deficit measured by NIHSS at Day 2, 7, 30, and 90
Time frame: Day 2, 7, 30, and 90 from stroke onset
Functional independence
Change from baseline in improving functional independence (mRS 0-2) at Day 30
Time frame: 30 days from stroke onset
Activities of daily living
Change from baseline in activities of daily living (by BartheI Index) on Day 30 and 90
Time frame: 30 and 90 days from stroke onset
Hematoma growth
Hematoma growth from Day 1 to Day 2
Time frame: 2 days from stroke onset
Mortality
Mortality rate on Day 90
Time frame: 90 days from stroke onset
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