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Trial · Interventional

Not yet recruitingPhase 4Registry data

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

Short name CLINCH

NCTNCT06899464 (opens ClinicalTrials.gov in a new tab)Other id000101
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Not yet recruiting
Phase
Phase 4
Enrollment
30 participants (estimated)
Sponsor
Cardinal Stefan Wyszynski University · Other
Design
Randomized · Single masking
Countries
Not stated
Start
1 Oct 2025 (estimated)
Primary completion
1 Jan 2027 (estimated)
Completion
1 Apr 2027 (estimated)
First posted
28 Mar 2025
Last update posted
28 Mar 2025
Conditions
Intracerebral Hemorrhage · Hemorrhagic Stroke, Intracerebral · Hemorrhagic Stroke · Stroke

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2025202620272028
  1. Ph 4

    CLINCH

    NCT06899464

    est. 1 Oct 2025 to est. 1 Apr 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • 14-day Cerebrolysin treatmentDrug
  • Standard of Care (SOC)Other

Arms2

  • Experimental

    Cerebrolysin

    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.

  • Placebo comparator

    Placebo

    Standard of care

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Efficacy Outcome

    Time frame · 90 days from stroke onset

    Registry description

    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

    Registry description

    Number of Serious Adverse Events until Day 30

Secondary outcomes(5)

  1. Neurological deficit

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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    Hematoma growth from Day 1 to Day 2

  5. Mortality

    Time frame · 90 days from stroke onset

    Registry description

    Mortality rate on Day 90

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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