Safety and Feasibility of Using Cerebrolysin in the Treatment of Primary Intracerebral Hemorrhage - a Prospective Randomized Open Blinded End-point Trial

Launched by CARDINAL STEFAN WYSZYNSKI UNIVERSITY · Mar 21, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a treatment called Cerebrolysin for people who have experienced a primary intracerebral hemorrhage, which is a type of stroke caused by bleeding in the brain. The study will take place in specialized stroke treatment centers in Poland and will involve patients who are between 18 and 80 years old, have had a stroke within the last 6 hours, and meet specific health criteria. In total, 30 participants will be enrolled over a year, and they will receive Cerebrolysin daily for 14 days, along with standard care, while being closely monitored for any side effects and changes in their recovery.

Participants in this trial will have their health assessed on several occasions: right after starting treatment, and then again at 2 days, 7 days, 30 days, and 90 days after the stroke. This helps researchers understand how well the treatment works and whether it is safe. It's important to note that some individuals may not be eligible to participate due to certain medical conditions or histories. Overall, the goal is to see if Cerebrolysin can help improve recovery for those affected by this kind of stroke.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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