Traumatic Brain Injury
Conditions
Interventions
control group:placebo
Levoxiracetam(4g/d):drug
Levoxiracetam(6g/d):drug
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-75 years old (including both endpoints), both genders. 2) Traumatic brain injury meeting all of the following conditions: ? Clear evidence of head trauma in the current diagnosis, including closed head injury, or head injury with cerebrospinal fluid leakage and/or ear or nasal discharge and/or intracranial air. ? MRI or CT confirms intracranial hemorrhage above the cerebellar tentorium (including contusions, subarachnoid hemorrhage, epidural hematoma, subdural hematoma, intracerebral hematoma, etc.), with or without transient loss of consciousness. ? Injury severity of mild to moderate (GCS score 10-15). ? Stable condition within 72 hours after traumatic brain injury, receiving conservative treatment, without surgical intervention (except for non-general anesthesia or non-basal anesthesia intracranial pressure monitoring). 3) Mini-Mental State Examination (MMSE) score below normal, with diagnostic cutoff values determined by different educational levels: illiterate (no education) =19 points, elementary school education =22 points, junior high school and above education =26 points. 4)Informed consent form signed by the guardian and/or the patient agreeing to participate in this clinical trial.
Exclusion criteria
Exclusion criteria: 1)Known or suspected allergies to the investigational drug or its components. 2)Use of contraindicated drugs or other medications that improve cognitive function as listed in the protocol after injury. 3)History of severe head trauma, cerebrovascular accidents, or structural intracranial abnormalities. 4)Conditions such as speech/hearing impairments that prevent completing cognitive function assessments. 5)Occurrence of a secondary brain injury following the current head trauma. 6)Individuals requiring craniotomy or external ventricular drainage. 7)Concurrent severe major organ injuries or serious complications that may affect the subject's life. 8)Patients with active seizures within the past year. 9) Patients with severe liver or kidney diseases and abnormal liver/kidney function tests (ALT, AST = 3 times the upper limit of normal, Scr > upper limit of normal). 10)Patients with severe heart, lung, blood and hematopoietic system disorders, gastrointestinal disorders, or other severe or progressive systemic diseases. 11)Past or current history of malignancy (except cured stage IB or lower cervical cancer, non-invasive basal cell or squamous cell skin cancer; complete remission [CR] > 10 years for breast cancer, CR > 10 years for malignant melanoma, CR > 5 years for other malignancies). 12)Patients with neurological or psychiatric disorders who are unable or unwilling to cooperate. 13)Pregnant, lactating women, or those with recent plans for reproduction. 14)Subjects considered unsuitable for participation in the clinical trial by the investigator. 15)Participation in another clinical trial and use of investigational drugs within the past 3 months prior to the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LOTCA score; | — |
Countries
China
Contacts
Public ContactRongcai Jiang
Tianjin Medical University General Hospital
Outcome results
None listed