A Phase 4 interventional study of 14-day Cerebrolysin treatment and Standard of Care (SOC) in Intracerebral Hemorrhage, Hemorrhagic Stroke, Intracerebral and Hemorrhagic Stroke, sponsored by Cardinal Stefan Wyszynski University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by Cardinal Stefan Wyszynski University · Phase 4, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Cardinal Stefan Wyszynski University is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cerebrolysin infusion (50 ml mixed with 250 mL of saline) will be initiated as soon as possible and within 6 hours of stroke onset. Cerebrolysin treatment will be continued (50 ml/d) once daily until day 14.
Drug: 14-day Cerebrolysin treatment
Standard of care
Other: Standard of Care (SOC)
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
No study locations are listed for this record.
Plan to share: Yes
Supporting information: Study protocol, Icf, Csr
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Cardinal Stefan Wyszynski University