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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Efficacy Outcome [Срок оценки: 90 days from stroke onset]
• Safety Outcome [Срок оценки: 30 days from stroke onset]

Вторичные конечные точки (5)

• Neurological deficit [Срок оценки: Day 2, 7, 30, and 90 from stroke onset]
• Functional independence [Срок оценки: 30 days from stroke onset]
• Activities of daily living [Срок оценки: 30 and 90 days from stroke onset]
• Hematoma growth [Срок оценки: 2 days from stroke onset]
• Mortality [Срок оценки: 90 days from stroke onset]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06899464 · 000101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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