Health TrialsbyHealthPanel

Prophylactic Anti-epileptic Regimen in Traumatic Brain Injury

ConditionsAntiepileptic Efficacy and SafetyBrain Injuries
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorAssiut University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Anti-Epileptic

    Drug

    The anti-epileptic drugs will take three months

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Group A1 intervention
Group B: Group B(control group)0 interventions

Trial outcomes

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).

Time frame
3 months

Secondary outcomes

1

Assess neurological outcomes

Assess the neurolgical outcomes by using the Glasgow Outcome Scale (GOS) at discharge

Time frame
during the 3 months
2

Assess in-hospital mortality rates

To evaluate in-hospital mortality rates in both groups.

Time frame
During hospitalization (assessed up to 7 days)]
3

Escalation of anti-epileptic therapy

Need for escalation of anti-epileptic therapy

Time frame
During the 3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: