Head Injuries Clinical Trial
OBJECTIVES: I. Determine whether treating head injured patients with valproate sodium will
reduce the risk of developing seizures as a result of the head injury.
II. Determine the safety of valproate, the appropriate dose, and the effect valproate may
have on the recovery of the brain's ability to compute numbers, solve problems, remember
information, and control the movement of limbs after head injury.
PROTOCOL OUTLINE: This is a randomized, double blind trial involving 3 treatment groups.
On day 1, controls receive phenytoin IV over 1 hour. On days 2 through 7, controls receive 2
doses each of phenytoin and placebo daily, intravenously. From day 8 through 6 months,
controls receive placebo IV 4 times daily, then placebo tablets are administered.
On day 1, the experimental group receives a loading dose of valproate sodium intravenously
over 1 hour within 24 hours of injury. Then, patients are divided into 2 subgroups.
From day 2 through 1 month, one group of patients receives valproate IV 4 times daily over 1
hour until tablets are tolerated. Patients receive placebo tablets by mouth 4 times daily
from month 2 through month 6.
On day 2, the other group of patients receives valproate IV 4 times daily and continues for
6 months until tablets (same dose) are tolerated.
If patients remain seizure free between day 8 and 6 months, the number of valproate or
placebo tablets are tapered over 1 week.
Each patient receives a full neuropsychological and psychosocial examination at 1, 6, and 12
months after injury.
Untreated observation of patients continues until 2 years after injury.
;
Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04505293 -
Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas
|
N/A | |
| Completed |
NCT01054846 -
Impact of Helmet Use in Preschool Children
|
N/A | |
| Completed |
NCT01113645 -
Impact of Cranioplasty On Cerebral Perfusion
|
N/A | |
| Recruiting |
NCT03619473 -
Standard Motorcycle Child Safety Helmet Initiative (MCHI) Program
|
N/A | |
| Completed |
NCT03353246 -
Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas
|
N/A | |
| Active, not recruiting |
NCT03905031 -
Defining the Operating Characteristics of NIRS in the Diagnosis of Pediatric Traumatic Intracranial Hemorrhage
|
N/A |