Status:
NOT_YET_RECRUITING
Safety and Feasibility of Using Cerebrolysin in the Treatment of Primary Intracerebral Hemorrhage - a Prospective Randomized Open Blinded End-point Trial
Lead Sponsor:
Cardinal Stefan Wyszynski University
Conditions:
Intracerebral Hemorrhage
Hemorrhagic Stroke, Intracerebral
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
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, bl...
Eligibility Criteria
Inclusion
- Age 18-80 years
- NIHSS ≥8 at randomization
- Stroke onset \<6h
- Pre-randomization head CT demonstrating an acute, primary lobar ICH
- ICH volume 30 to 80 mL
- Glasgow Coma Score (GCS) 5 to 12
- Pre-stroke independence (modified Rankin Score 0 to 2)
- Ability to provide informed consent
- No history of prior stroke
Exclusion
- Hemorrhage caused by head trauma
- Medical history or neuroimaging findings suggestive of ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, venous sinus thrombosis, mass or tumor, hemorrhagic conversion of an ischemic infarct
- Bilateral fixed dilated pupils
- Extensor motor posturing
- Intraventricular extension of the hemorrhage is visually estimated to involve \>50% of either of the lateral ventricles
- Primary Thalamic and basal ganglia ICH
- Infratentorial intraparenchymal hemorrhage including midbrain, pontine, or cerebellar
- Current use of low molecular weight heparins in therapeutic dose
- Evidence of active bleeding
- Uncorrected coagulopathy or known clotting disorder
- Platelet count \< 75,000, International Normalized Ratio (INR) \> 1.4 after correction
- End stage renal disease
- Patients with a mechanical heart valve
- End-stage liver disease
- Epilepsy with grand mal seizures
- History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
- Positive urine or serum pregnancy test in female subjects without documented history of surgical sterilization or post-menopausal
- Known life-expectancy of less than 6 months
- No reasonable expectation of recovery, Do-Not-Resuscitate (DNR), or comfort measures only prior to randomization
- Participation in a concurrent interventional medical investigation or clinical trial
- Inability or unwillingness of subject or legal guardian/representative to give written informed consent
- Any condition that would represent a contraindication for cerebrolysin administration
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06899464
Start Date
October 1 2025
End Date
April 1 2027
Last Update
March 28 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.