Prophylactic Anti-epileptic Regimen in Traumatic Brain Injury

Role of Prophylactic Anti-epileptic Regimen in Traumatic Brain Injury

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

Study Overview

• Status: Not yet recruiting
• Conditions: Brain Injuries; Antiepileptic Efficacy and Safety
• Intervention / Treatment: Drug: Anti-Epileptic

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.

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Geabel Al-Qubli, Master candidate; Phone Number: 01034732278; Email: geabelalqubli1996@gmail.com
• Study Contact Backup: Name: Mohammed Taghyan, PhD; Phone Number: 01006876892; Email: mtaghyan@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Study Population: Patients with TBI admitted to the hospital and evaluated clinically and radiologically on admission.

A complete assessment will include:

• Medical history (age, gender).
• Physical examination (temperature, blood pressure, heart rate, respiratory rate, chest auscultation)
• Glasgow Coma Scale (GCS).
• Laboratory tests (complete blood count, sodium, potassium, blood urea nitrogen, creatinine, hepatic profile).
• Brain computed tomography (CT).
• Clinical monitoring, including antiepileptic drug dosing, adverse events, and mortality during hospitalisation.

Description

Inclusion Criteria:

1. Patients with a confirmed diagnosis of traumatic brain injury (clinical and/or radiological), including both surgical and conservative management
2. Admission within 24 hours of injury
3. Eligible for antiepileptic prophylaxis according to clinical guidelines
4. Written informed consent obtained.

Exclusion Criteria:

1. Pre-existing epilepsy or seizure disorder.
2. Seizure episode before or during admission unrelated to acute TBI.
3. Prior use of antiepileptic drugs before admission.
4. Severe renal impairment (creatinine clearance <30 mL/min).
5. Hepatic failure.
6. Pregnancy or lactation.
7. Known hypersensitivity to antiepileptic drugs

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; Group A will take the antiepileptic drug for prophylaxis, in addition to the standard drugs for traumatic brain injury, for 3 months.	Drug: Anti-Epileptic; The anti-epileptic drugs will take three months; Other Names: Anti-Epileptic Drug: Anti-epileptic (administered for 3 months)
Group B(control group); Group B: The control group will take the standard treatment for traumatic brain injury for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of seizure	Number of documented seizure episodes per participant, as recorded by clinical observation during the follow-up period (3 months).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess neurological outcomes	Assess the neurolgical outcomes by using the Glasgow Outcome Scale (GOS) at discharge	during the 3 months
Assess in-hospital mortality rates	To evaluate in-hospital mortality rates in both groups.	During hospitalization (assessed up to 7 days)]
Escalation of anti-epileptic therapy	Need for escalation of anti-epileptic therapy	During the 3 months

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Mohammed A Taghyan, PhD, Assiut University; Study Director: Ahmed A Ismail, PhD, Assiut University; Study Director: Ismail A Taha, PhD, Assiut University

Publications and helpful links

General Publications

• Ng SY, Lee AYW. Traumatic brain injuries: pathophysiology and potential therapeutic targets. Frontiers in cellular neuroscience. 2019;13:484040.
• Dewan MC, Rattani A, Gupta S, Baticulon RE, Hung Y-C, Punchak M, et al. Estimating the global incidence of traumatic brain injury. Journal of neurosurgery. 2018;130(4):1080-97.
• Faul M, Wald MM, Xu L, Coronado VG. Traumatic brain injury in the United States: emergency department visits, hospitalizations, and deaths, 2002-2006. 2010.
• Stocchetti N, Zanier ER. Chronic impact of traumatic brain injury on outcome and quality of life: a narrative review. Critical Care. 2016;20(1):148.
• Centers for Disease Control and Prevention. National center for health statistics: mortality data on CDC WONDER. https://wonder.cdc.gov/mcd.html 2026.
• Bruns Jr J, Hauser WA. The epidemiology of traumatic brain injury: a review. Epilepsia. 2003;44:2-10.
• han A, Muntaha ST, Ayaz H, Tariq A, Mughal H. Use Of Anti-Epileptics For Seizure Prophylaxis After Traumatic Brain Injury In The Pediatric Population. Journal of Rawalpindi Medical College. 2024;28(4).
• Khan SA, Bhatti SN, Alam A, Afridi EAK, Muhammad G, Zadran KK, et al. Comparison of efficacy of phenytoin and levetiracetam for prevention of early post traumatic seizures. Journal of Ayub Medical College Abbottabad. 2016;28(3):455-60.
• Surtees T-L, Kumar I, Garton HJL, Rivas-Rodriguez F, Parmar H, McCaffery H, et al. Levetiracetam Prophylaxis for Children Admitted With Traumatic Brain Injury. Pediatric Neurology. 2022;126:114-9.
• Malison N. Anti-epileptic for seizure prophylaxis in traumatic brain injury patients. The Bangkok Medical Journal. 2017;13(2):87-.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: April 4, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Anti-epileptic, Brain Injury, Efficacy, Safety, Trauma
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Injuries; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Central Nervous System Agents; Anticonvulsants
• Other Study ID Numbers: 2026 (Capital Health Development Research Special Project)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No