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Not yet recruiting NCT06899464

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

Phase IV Interventional Intracerebral Hemorrhage Hemorrhagic Stroke, Intracerebral Hemorrhagic Stroke Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 14-day Cerebrolysin treatment, Standard of Care (SOC).
Who it may be relevant to
Registry conditions: Intracerebral Hemorrhage, Hemorrhagic Stroke, Intracerebral, Hemorrhagic Stroke, Stroke. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Safety and Feasibility of Using Cerebrolysin in the Treatment of Primary Intracerebral Hemorrhage

Overview

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.

Interventions

  • Drug 14-day Cerebrolysin treatment
    14-day cerebrolysin treatment initiated within 6 hours of onset of stroke
  • Other Standard of Care (SOC)
    Standard of care treatment

Primary outcome measures

  • Efficacy Outcome [Time frame: 90 days from stroke onset]
  • Safety Outcome [Time frame: 30 days from stroke onset]
Secondary outcome measures (5)
  • Neurological deficit [Time frame: Day 2, 7, 30, and 90 from stroke onset]
  • Functional independence [Time frame: 30 days from stroke onset]
  • Activities of daily living [Time frame: 30 and 90 days from stroke onset]
  • Hematoma growth [Time frame: 2 days from stroke onset]
  • Mortality [Time frame: 90 days from stroke onset]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
  • Positive urine or serum pregnancy test in female subjects without documented history of surgical sterilization or post-menopausal
  • Known life-expectancy of less than 6 months
  • 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
  • Inability or unwillingness of subject or legal guardian/representative to give written informed consent
  • Any condition that would represent a contraindication for cerebrolysin administration

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06899464 · 000101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗