Disorder of Consciousness, Hemorrhagic Stroke
Conditions
Brief summary
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
Interventions
DRUGCerebrolysin
30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously
DRUGControl
100 ml normal saline, days 4-17, once/day, IV
Sponsors
Konkuk University Medical Center
Ever Neuro Pharma GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coma Recovery Scale - revised | 2 days after randomization | Assessing the degree of disorders of consciousness |
| Positron Emitting Tomography | 2 days after randomization | Assessing the degree of brain neural network activity |
Countries
South Korea
Contacts
CONTACTJongmin Lee, M.D., Ph.D.
Outcome results
None listed