Prophylactic Anti-epileptic Regimen in Traumatic Brain Injury

NCT07535736 | Not Yet Recruiting

• 1 other identifier: 2026
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Antiepileptic Efficacy and Safety; Brain Injuries

Keywords

Anti-epileptic, Brain Injury, Efficacy, Safety, Trauma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Assess neurological outcomes

  during the 3 months

• Assess in-hospital mortality rates

  During hospitalization (assessed up to 7 days)]

• Escalation of anti-epileptic therapy

  During the 3 months

Study Arms (2)

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

Group B(control group)

Group B: The control group will take the standard treatment for traumatic brain injury for 3 months.

Interventions

Anti-Epileptic DRUG

The anti-epileptic drugs will take three months

Also known as: Anti-Epileptic Drug: Anti-epileptic (administered for 3 months)

Group A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (10)

• Ng SY, Lee AYW. Traumatic brain injuries: pathophysiology and potential therapeutic targets. Frontiers in cellular neuroscience. 2019;13:484040.

  BACKGROUND

• 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.

  BACKGROUND

• Faul M, Wald MM, Xu L, Coronado VG. Traumatic brain injury in the United States: emergency department visits, hospitalizations, and deaths, 2002-2006. 2010.

  BACKGROUND

• 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.

  BACKGROUND

• Centers for Disease Control and Prevention. National center for health statistics: mortality data on CDC WONDER. https://wonder.cdc.gov/mcd.html 2026.

  BACKGROUND

• Bruns Jr J, Hauser WA. The epidemiology of traumatic brain injury: a review. Epilepsia. 2003;44:2-10.

  BACKGROUND

• 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).

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Malison N. Anti-epileptic for seizure prophylaxis in traumatic brain injury patients. The Bangkok Medical Journal. 2017;13(2):87-.

  BACKGROUND

MeSH Terms

Conditions

Brain Injuries; Wounds and Injuries

Interventions

Anticonvulsants

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System

Intervention Hierarchy (Ancestors)

Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Mohammed A Taghyan, PhD

  Assiut University

  STUDY CHAIR

• Ahmed A Ismail, PhD

  Assiut University

  STUDY DIRECTOR

• Ismail A Taha, PhD

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Geabel Al-Qubli, Master candidate

CONTACT

01034732278; geabelalqubli1996@gmail.com

Mohammed Taghyan, PhD

CONTACT

01006876892; mtaghyan@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master candidate at Neurosurgery

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: April 17, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share