NCT07535736

Prophylactic Anti-epileptic Regimen in Traumatic Brain Injury

Role of Prophylactic Anti-epileptic Regimen in Traumatic Brain Injury

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effectiveness and safety of anti-epileptic drugs in the prevention of early and late post-traumatic seizures among patients with trauma brain injury

Detailed description

Traumatic brain injury (TBI) is one of the leading causes of death and disabilities worldwide. It has been estimated that 64-74 million individuals experience TBI from all causes each year. According to the Centers for Disease Control and Prevention (CDC), an estimated 1.7 million people sustain a TBI every year in the USA. TBI can be associated with chronic consequences such as physical and psychological disorders. In 2021, there were over 69,000 deaths because of TBI in the USA, with about 190 TBI-related deaths every day. The risk of having a TBI is highest among adolescents, young adults, and older people. Post-traumatic seizures can be classified into immediate, that is, occurring within the first 24 hours; early, occurring within 1-7 days of life; and late, if seizures occur after 7 days of life. Prophylactic use of anti-epileptic drugs during the first 7 days is protective against early seizures. A lower incidence of seizures was observed in patients who received anti-epileptic prophylaxis. The current guidelines for post-TBI seizure prophylaxis emphasise the effectiveness of seizure control, and phenytoin and levetiracetam are frequently prescribed. Levetiracetam is a new antiepileptic drug that is used for prophylaxis in post-traumatic brain injury. Levetiracetam has low plasma protein binding and a lower risk of drug interactions and adverse events. Levetiracetam's major metabolic pathway is hydrolysis, not via CYP450. However, the drug is eliminated via the kidneys, so patients who are critically ill or suffer from renal insufficiency may require dosage adjustment. Therapeutic drug monitoring may be required in complicated cases. A few side effects associated with levetiracetam include headache, nausea, vomiting, drowsiness, dizziness, and behavioural changes. Although current guidelines recommend levetiracetam for post-TBI seizure prophylaxis, there is no available data regarding its effectiveness outcomes at Assiut University Trauma Hospital. This highlights the need for a local clinical evaluation to assess prescribing practices and patient outcomes in this setting. Therefore, this study aimed to evaluate the effectiveness of anti-epileptic drugs compared with the control group in preventing early and late post-traumatic seizures in patients with TBI at Assiut University Trauma Hospital.

Conditions

• Antiepileptic Efficacy and Safety
• Brain Injuries

Interventions

Type	Name	Description
DRUG	Anti-Epileptic	The anti-epileptic drugs will take three months

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-05-30
• Completion: 2027-06-30
• First posted: 2026-04-17
• Last updated: 2026-04-17