NCT06899464Not yet recruitingPhase 4
Safety and Feasibility of Using Cerebrolysin in the Treatment of Primary Intracerebral Hemorrhage - a Prospective Randomized Open Blinded End-point Trial
Safety and Feasibility of Using Cerebrolysin in the Treatment of Primary Intracerebral Hemorrhage
Source: ClinicalTrials.gov · Last updated 28 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 21 Mar 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Cardinal Stefan Wyszynski University
- Diseases
- Stroke
- NCT number
- NCT06899464
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 30
- From 1 Oct 2025 to the primary completion date, 1 Jan 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
- Intraventricular extension of the hemorrhage is visually estimated to involve \>50% of either of the lateral ventricles
- Infratentorial intraparenchymal hemorrhage including midbrain, pontine, or cerebellar
- Evidence of active bleeding
- Uncorrected coagulopathy or known clotting disorder
- 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
- Any condition that would represent a contraindication for cerebrolysin administration
Lab values
- Platelet count \< 75,000, International Normalized Ratio (INR) \> 1.4 after correction
- Positive urine or serum pregnancy test in female subjects without documented history of surgical sterilization or post-menopausal
Other
- Bilateral fixed dilated pupils
- Extensor motor posturing
- Primary Thalamic and basal ganglia ICH
- Current use of low molecular weight heparins in therapeutic dose
- Known life-expectancy of less than 6 months
- Inability or unwillingness of subject or legal guardian/representative to give written informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.