Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06899464

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

14-day Cerebrolysin treatment

Drug

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

Standard of Care (SOC)

Other

Standard of care treatment

Primary outcomes

  1. Efficacy Outcome

    Time frame: 90 days from stroke onset

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

  2. Safety Outcome

    Time frame: 30 days from stroke onset

    Number of Serious Adverse Events until Day 30

Secondary outcomes

  1. Neurological deficit

    Time frame: Day 2, 7, 30, and 90 from stroke onset

    Change from baseline in neurological deficit measured by NIHSS at Day 2, 7, 30, and 90

  2. Functional independence

    Time frame: 30 days from stroke onset

    Change from baseline in improving functional independence (mRS 0-2) at Day 30

  3. Activities of daily living

    Time frame: 30 and 90 days from stroke onset

    Change from baseline in activities of daily living (by BartheI Index) on Day 30 and 90

  4. Hematoma growth

    Time frame: 2 days from stroke onset

    Hematoma growth from Day 1 to Day 2

  5. Mortality

    Time frame: 90 days from stroke onset

    Mortality rate on Day 90

Study contacts

Contact information is provided by the study sponsor or research team.

Adam Kobayashi, M.D. Ph.D.

CONTACT

[email protected]

+48602266498

Kinga Rutkowska, M.Sc.Pharm.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Cardinal Stefan Wyszynski University

Other

Registry information

Official study title

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

Acronym: CLINCH

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 28, 2025
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.