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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
12
30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously
100 ml normal saline, days 4-17, once/day, IV
Konkuk University Medical Center Research Coordinating Center
Seoul, South Korea
RECRUITINGComa Recovery Scale - revised
Assessing the degree of disorders of consciousness
Time frame: 2 days after randomization
Coma Recovery Scale - revised
Assessing the degree of disorders of consciousness
Time frame: 17 days after randomization
Positron Emitting Tomography
Assessing the degree of brain neural network activity
Time frame: 2 days after randomization
Positron Emitting Tomography
Assessing the degree of brain neural network activity
Time frame: 17 days after randomization
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