CERebrolysine Effect on Blood-brain Barrier / Endothelium Integrity During Reperfusion Therapy of acUte Ischemic Stroke (CERBERUS Study)
Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The study investigates whether Cerebrolysin stabilizes blood-brain barrier integrity in a manner that can be monitored using serum levels of the principal tight junction proteins, e.g., occludin (OCL), claudin-5 (CLN), and zonula occludens-1 (ZO-1), or other molecules known to be involved in BBB degradation, e.g., S100B and whether it protects against hemorrhagic transformation in ischemic stroke patients after reperfusion therapy (i.e. thrombolysis and/or mechanical thrombectomy).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• acute ischemic stroke patients
• informed consent
Locations
Other Locations
Poland
University Hospital
RECRUITING
Poznan
Contact Information
Primary
Slawomir Michalak, Prof.
swami@ump.edu.pl
+48 61 8691 535
Backup
Joanna Rybacka-Mossakowska, MD, PhD
joannarybacka@gmail.com
+48 61 8691 459
Time Frame
Start Date: 2023-01-10
Estimated Completion Date: 2025-03-31
Participants
Target number of participants: 350
Treatments
No_intervention: Thrombolysis and/or mechanical thrombectomy
patients included for reperfusion therapy (intravenous thrombolysis and/or mechanical thrombectomy - comparator
Experimental: Cerebrolysin
patients included for reperfusion therapy (intravenous thrombolysis and/or mechanical thrombectomy and treated with Cerebrolysin
No_intervention: No reperfusion therapy / no cerebrolysin
patients not referred to reperfusion therapy nor Cerebrolysin
Related Therapeutic Areas
Sponsors
Leads: Poznan University of Medical Sciences