1. Background: Preliminary studies have suggested that valproate acid (VPA) may promote neuron survival, inhibit apoptosis, decrease the neuron function deficit in cerebral ischemia, and promote the brain functional recovery after traumatic brain injury (TBI). Besides, in the guide of prevention and treatment of epilepsy in 2007, VPA was one of the antiepileptic drugs which were suggested to prevent early epilepsy after TBI (less than 7 days). 2. Objectives: Our main objective was to evaluate whether VPA could protect brain and improve recovery of brain function after severe TBI. The secondary objective was to explore whether VPA could prevent late epilepsy after severe TBI (more than 7 days). 3. Methods: We would enroll 160 patients who were in a vegetative or minimally conscious state 4 to 16 weeks after TBI and who were receiving inpatient rehabilitation. Patients were randomly assigned to receive VPA or placebo for 4 weeks and were followed for 2 weeks after the treatment was discontinued. The rate of functional recovery on the Disability Rating Scale (DRS; range, 0 to 29, with higher scores indicating greater disability) was compared over the 4 weeks of treatment (primary outcome) and during the 2-week washout period with the use of mixed-effects regression models.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
160
valproate acid is a common drug which is applied for epilepsy prevention and treatment.
Institute of Neurosurgery, Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China
RECRUITINGDRS scores
The DRS score includes measures of eye opening, verbalization, and motor response (derived from the Glasgow Coma Scale); cognitive understanding of feeding, dressing, and grooming; degree of assistance and supervision required; and employability. Scores range from 0 to 29, with higher values indicating greater disability.
Time frame: On the 0,7th,14th,21st,28th,35th,42nd days since admitted into the study
the time of break out and state of epilepsy
When the patient were admitted into the study, the breakout and the severity of epilepsy would be monitored and treated until the end of the trial.
Time frame: from 0 to 42 days when the epilepsy break out
brain MRI scan
Brain MRI scan is applied to monitor the degree and progress of the brain damage.
Time frame: 6 weeks after treatment
the blood concentration of VPA
the blood was collected to detect the concentration about 2 hours after the medication of VPA
Time frame: On the 0,7th,14th,21st,28th,35th,42nd days since admitted into the study
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