Antiepileptic Efficacy and Safety, Brain Injuries
Conditions
Keywords
Anti-epileptic, Brain Injury, Efficacy, Safety, Trauma
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
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.
Interventions
DRUGAnti-Epileptic
The anti-epileptic drugs will take three months
Sponsors
Assiut University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of seizure | 3 months | Number of documented seizure episodes per participant, as recorded by clinical observation during the follow-up period (3 months). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess neurological outcomes | during the 3 months | Assess the neurolgical outcomes by using the Glasgow Outcome Scale (GOS) at discharge |
| Assess in-hospital mortality rates | During hospitalization (assessed up to 7 days)] | To evaluate in-hospital mortality rates in both groups. |
| Escalation of anti-epileptic therapy | During the 3 months | Need for escalation of anti-epileptic therapy |
Contacts
CONTACTGeabel Al-Qubli, Master candidate
CONTACTMohammed Taghyan, PhD
STUDY_CHAIRMohammed A Taghyan, PhD
Assiut University
STUDY_DIRECTORAhmed A Ismail, PhD
Assiut University
STUDY_DIRECTORIsmail A Taha, PhD
Assiut University
Outcome results
None listed