Cerebrolysin for prolonged disorders of consciousness after hemorrhagic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional Phase 4 protocol compares daily intravenous Cerebrolysin (30 mL Cerebrolysin mixed with 70 mL saline) to a control infusion of 100 mL saline, administered once daily from days 4–17 after stroke onset. Eligible participants are adults aged 19–80 who have been in a vegetative state or minimally conscious state for more than four weeks after a hemorrhagic stroke and meet EEG and comorbidity criteria. Primary outcomes include recovery of consciousness measured by the Coma Recovery Scale–Revised and changes in brain metabolism on FDG-PET, with assessments during and after the treatment period. Treatments and follow-up are conducted at a single center (Konkuk University Medical Center) with participants assigned to either the Cerebrolysin arm or the control arm.

Why it matters

Who can join: the full rules

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

Where it's running

• Konkuk University Medical Center Research Coordinating Center
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Jongmin Lee, M.D., Ph.D.
• Email: jongminleemd@gmail.com
• Phone: +821063558073

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.