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Comparison of Two Medicines Phenytoin and Levetiracetam to Prevent Seizures after Traumatic Brain Injury

To Assess Efficacy, Safety, and Clinical Outcomes of Phenytoin versus Levetiracetam for Seizure Prophylaxis in patient with Traumatic Brain Injury: A Prospective Observational Comparative Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/11/097042
Enrollment
80
Registered
2025-11-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: S098- Other specified injuries of head

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil

Sponsors

Dr Ishankumar Goyani
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients diagnosed with Acute Traumatic Brain Injury patients diagnosed (confirmed by clinical assessment and/or CT/MRI). Patients diagnosed with moderate to severe TBI (GCS less then or equal to 12). Patients willing to signed written consent.

Exclusion criteria

Exclusion criteria: Penetrating head injuries (due to different seizure risk profiles). Pre-existing seizures, epilepsy or neurological disorders requiring AEDs. Patients Contraindicated to phenytoin or levetiracetam (e.g., hypersensitivity, severe hepatic/renal impairment). Patients transferred to other facilities. Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
To compare Efficacy and Safety of Phenytoin vs Levetiracetam to address seizure prevention. To compare Clinical Outcomes of Phenytoin vs Levetiracetam based on hospital stay, ICU stay, mortality. Timepoint: First follow up at 1st week Second follow up at 1st month Third follow up at 3rd month—

Secondary

MeasureTime frame
Cost effectiveness between phenytoin vs Levetiracetam. Timepoint: First follow up at 1st week Second follow up at 1st month Third follow up at 3rd month—

Countries

India

Contacts

Public ContactDr Ishankumar Goyani

Gajra Raja Medical College

rajaryagrmc@gmail.com9300793791

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026