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

NCT06899464 | Not Yet Recruiting Phase 4

• 1 other identifier: 000101
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Intracerebral Hemorrhage; Hemorrhagic Stroke, Intracerebral; Hemorrhagic Stroke; Stroke

Keywords

Cerebrolysin in stroke; neuroprotection in stroke; Cerebrolysin in hemorrhagic stroke

Outcome Measures

Primary Outcomes (2)

• Efficacy Outcome

  Change from baseline in functional independence (mRS 0-2) at Day 90 following stroke onset

  90 days from stroke onset

• Safety Outcome

  Number of Serious Adverse Events until Day 30

  30 days from stroke onset

Secondary Outcomes (5)

• Neurological deficit

  Day 2, 7, 30, and 90 from stroke onset

• Functional independence

  30 days from stroke onset

• Activities of daily living

  30 and 90 days from stroke onset

• Hematoma growth

  2 days from stroke onset

• Mortality

  90 days from stroke onset

Study Arms (2)

Cerebrolysin

EXPERIMENTAL

Cerebrolysin infusion (50 ml mixed with 250 mL of saline) will be initiated as soon as possible and within 6 hours of stroke onset. Cerebrolysin treatment will be continued (50 ml/d) once daily until day 14.

Drug: 14-day Cerebrolysin treatment

Placebo

PLACEBO COMPARATOR

Standard of care

Other: Standard of Care (SOC)

Interventions

14-day Cerebrolysin treatment DRUG

14-day cerebrolysin treatment initiated within 6 hours of onset of stroke

Cerebrolysin

Standard of Care (SOC) OTHER

Standard of care treatment

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardinal Stefan Wyszynski University: lead

MeSH Terms

Conditions

Cerebral Hemorrhage; Hemorrhagic Stroke; Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Adam Kobayashi, M.D. Ph.D.

CONTACT

+48602266498; a.kobayashi@uksw.edu.pl

Kinga Rutkowska, M.Sc.Pharm.

CONTACT

kinga.rutkowska@uksw.edu.pl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 28, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR