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Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness

Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness

Recruiting
19-120 years
All
Phase 4

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Overview

Object: To determine the effect of cerebrolysin on prolonged disorders of consciousness caused by hemorrhagic stroke.

Participants: patients with prolonged disorders of consciousness due to severe traumatic brain injury

Intervention: 30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously or 100 ml normal saline, days 4-17, once/day, IV

Comparison: cerebrolysin group versus control group

Outcome: Coma Recovery Scale-revised, FDG-PET signal

Eligibility

Inclusion Criteria

  1. Patients with hemorrhagic stroke confirmed by CT or MRI
  2. Patients who have been in disorders of consciousness for more than 4 weeks after the onset of hemorrhagic stroke
  3. Patients in a vegetative state or minimally conscious state (Coma Recovery Scale -revised: CRS-R assessment)
  4. Age: 19 to 80 years of age
  5. Patients who have voluntarily given written informed consent to participate in the study by themselves or their legal representative.

Exclusion Criteria

  1. Patients with confirmed epileptiform discharges on EEG
  2. Patients with brain parenchymal defects
  3. Patients with advanced liver, kidney, cardiac, or pulmonary disease.
  4. Chronic treatment with medications that may affect consciousness, such as antidepressants, antipsychotic drugs, nootropic drugs, and vasodilators.
  5. History of serious illness within the last two years (cancer, hematologic, renal, hepatic, or coronary artery disease, psychiatric illness, diabetes, myocardial infarction, epilepsy), no evidence of secondary damage to major organs, and well-controlled diabetes or hypertension.
  6. Alcohol or drug abuse or dependence within the last 2 years (DSM-V criteria).
  7. Significant systemic disease or unstable medical condition that may compromise compliance with the study protocol.
  8. Administration of a contraindicated drug is essential for medical purposes.
  9. Contraindications to the study drug (cerebrolysin).
  10. Participation in another therapeutic study

Study details
    Disorder of Consciousness
    Hemorrhagic Stroke

NCT04427241

Konkuk University Medical Center

13 May 2026

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