Role and Impact of Cerebrolysin for Ischemic Stroke Care.
Dafin F Mureșanu, Livia Livinț Popa, Diana Chira...
https://pubmed.ncbi.nlm.nih.gov/35268364/Actively Recruiting
Led by University Medical Centre Ljubljana · Updated on 2025-07-09
30
Participants Needed
1
Research Sites
13 weeks
Total Duration
Researchers are evaluating the safety and effects of Cerebrolysin during early rehabilitation in patients with moderate to severe neurological impairment after an acute ischemic stroke. The study aims to determine how Cerebrolysin, given in addition to standard stroke care, impacts recovery and neurological outcomes at discharge and 90 days post-stroke. This research is conducted at the Department of Vascular Neurology and Intensive Neurological Therapy, University Medical Centre Ljubljana, focusing on a specific patient group with NIHSS scores between 6 and 12. Patients in the study are divided into two groups one receiving Cerebrolysin plus standard care, and a control group receiving only standard treatment. Cerebrolysin is given as a 30 ml intravenous infusion daily for 10 consecutive days, diluted to 100 ml with saline and infused over 15 minutes. Both groups receive standard stroke treatments including reperfusion therapy, secondary prevention, and rehabilitation therapies like physiotherapy, occupational therapy, speech therapy, and neuropsychological assessments. Participants will be assessed using various tests and scales, including the Action Research Arm Test ARAT at 90 days post-stroke as the primary outcome. Additional evaluations include the NIH Stroke Scale, Modified Rankin Score, Extended Barthel Index, De Morton Mobility Index, and Montreal Cognitive Assessment at discharge and 90 days. The study monitors safety and treatment effects over this period, with participant involvement including clinical assessments and rehabilitation according to their needs.
CONDITIONS
Cerebrolysin in Early Stroke Rehabilitation - Tertiary Study
M
Matija Zupan, MD, PhD
M
Marjan Zaletel, MD, PhD
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University Medical Centre Ljubljana
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 days
Participants receive Cerebrolysin treatment as an adjunct to standard care or standard treatment alone for acute ischemic stroke. Cerebrolysin is given by intravenous infusion daily for 10 consecutive days in the experimental group, while all participants receive standard neurorehabilitation and stroke care according to local guidelines.
Daily visits for 10 days (in-person)
Duration - Approximately 3 months
Participants are assessed for neurological and functional outcomes at discharge and approximately 90 days after stroke to evaluate recovery and safety.
2 visits (at discharge and 90 days post-stroke, in-person)
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Dafin F Mureșanu, Livia Livinț Popa, Diana Chira...
https://pubmed.ncbi.nlm.nih.gov/35268364/University Medical Centre Ljubljana
Lead Sponsor