Cerebrolysin's effect on blood-brain barrier in acute ischemic stroke
CERebrolysine Effect on Blood-brain Barrier / Endothelium Integrity During Reperfusion Therapy of acUte Ischemic Stroke (CERBERUS Study)
This study is testing if Cerebrolysin can help protect the blood-brain barrier in people who have had an acute ischemic stroke to see if it reduces complications after treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Poznan University of Medical Sciences Academic / other |
| Locations | 1 site (Poznań) |
| Trial ID | NCT06078215 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of Cerebrolysin on stabilizing the blood-brain barrier (BBB) in patients with acute ischemic stroke. It aims to monitor serum levels of tight junction proteins and other biomarkers associated with BBB integrity and hemorrhagic transformation following reperfusion therapy. By evaluating these biomarkers, the study seeks to determine if Cerebrolysin can protect against complications that may arise after thrombolytic treatments. The research is conducted at the University Hospital in Poznań.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with acute ischemic stroke who can provide informed consent.
Not a fit: Patients with primary or metastatic brain tumors, severe kidney disease, or those who are hypersensitive to Cerebrolysin may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes for acute ischemic stroke patients by reducing the risk of hemorrhagic transformation.
How similar studies have performed: Other studies have shown promising results regarding the protective effects of Cerebrolysin on blood-brain barrier integrity, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * acute ischemic stroke patients * informed consent Exclusion Criteria: * no informed consent * primary or metastatic brain tumor * brain abscess * encephalitis * localized inflammation * sepsis * autoimmune diseases of central or peripheral nervous system * Cerebrolysin hypersensitivity / allergy * epilepsy * severe kidney disease
Where this trial is running
Poznań
- University Hospital — Poznań, Poland (Recruiting)
Study contacts
- Principal investigator: Slawomir Michalak, Prof. — Poznan University of Medical Sciences
- Study coordinator: Slawomir Michalak, Prof.
- Email: swami@ump.edu.pl
- Phone: +48 61 8691 535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.