CTRI/2024/05/067626尚未招募3 期
Management of Seizures after Traumatic brain injury - MAST
ational Institute of Mental Health and Neurosciences (NIMHANS)0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •MAST DURATION
- •Inclusion Criteria:
- •Patients aged =10 years with TBI managed in an NSU who have started on an phenytoin or levetiracetam due to an acute symptomatic seizure during acute hospitalisation
- •Patient or Legal Representative is willing and able to provide informed consent or in the absence of a legal representative, an Independent Healthcare Professional provides authorisation for patient enrolment
- •MAST PROPHYLAXIS
- •Inclusion Criteria:
- •Patients aged =10 years, with TBI managed in an NSU without an acute symptomatic seizure
- •Patient or Legal Representative is willing and able to provide informed consent or in the absence of a legal representative, an Independent Healthcare Professional provides authorisation for patient enrolment within 48 hours of admittance.
排除标准
- •MAST DURATION
- •Unsurvivable injury
- •Previous history of epilepsy
- •Patients who are on an AED pre-TBI
- •Patient who has been clinically prescribed an AED other than phenytoin or levetiracetam
- •Unwillingness to take products containing gelatin (animal products)
- •Severe lactose intolerance or any known hypersensitivity to study drug or any of its excipients
- •MAST PROPHYLAXIS
- •Post-traumatic seizures
- •Unsurvivable injury
- •Previous history of epilepsy
- •Patients who are on an AED pre-TBI
- •Pregnancy or breastfeeding
- •Unwillingness to take products containing gelatin (animal products)
- •Severe lactose intolerance or any known hypersensitivity to study drug or any of its excipients
- •Time interval from the time of admission to NSU to randomisation exceeds 48 hours
研究者
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