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临床试验/NCT07535736
NCT07535736尚未招募不适用

Role of Prophylactic Anti-epileptic Regimen in Traumatic Brain Injury

Assiut University0 个研究点目标入组 70 人开始时间: 2026年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
主要终点
Incidence of seizure

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Group A

Group A will take the antiepileptic drug for prophylaxis, in addition to the standard drugs for traumatic brain injury, for 3 months.

干预措施: Anti-Epileptic (Drug)

Group B(control group)

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

结局指标

主要结局

Incidence of seizure

时间窗: 3 months

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Geabel Abdullah Ahmed Al-Qubli

Master candidate at Neurosurgery

Assiut University

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