Trial to Prevent Early Seizures After Traumatic Brain Injury Using Phenytoin, Levetiracetam, or Placebo Evaluating Drug Effects, Genetic Factors, and Cost-Effectiveness

What this Trial Is About

Researchers are evaluating the prevention of early post-traumatic seizures PTS in patients with traumatic brain injury TBI. This multicentric, prospective, randomized, placebo-controlled, double-blinded study aims to compare the seizure incidence and effectiveness of two anti-epileptic drugs, phenytoin and levetiracetam, against a placebo. The study also investigates how genetic differences affect seizure occurrence and the safety and cost-effectiveness of these treatments. Participants will be randomly assigned to one of three groups the phenytoin group, the levetiracetam group, or the placebo group. The phenytoin group receives an intravenous loading dose followed by maintenance doses, transitioning to oral medication within one week post-injury. The levetiracetam group receives intravenous doses twice daily, then switches to oral extended-release tablets for one week. The placebo group receives matching saline infusions and placebo tablets over the same period. Genetic testing will be performed to analyze drug polymorphisms. During the study, participants will be monitored for clinical seizures within seven days after injury, with follow-ups at hospital discharge, six months, and one year. Assessments include Glasgow Coma Scale and Glasgow Outcome Scale scores, genetic polymorphism analysis, and a cost-effectiveness evaluation of the drugs. The total study duration involves monitoring seizure occurrence early after injury and longer-term clinical and functional outcomes.

Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial)