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临床试验/ISRCTN13200656
ISRCTN13200656进行中(未招募)3 期

Pharmacological management of seizures post traumatic brain injury (MAST trial)

Cambridge University Hospitals NHS Foundation Trust0 个研究点目标入组 1,649 人开始时间: 2020年10月20日最近更新:
适应症

试验速览

阶段
3 期
状态
进行中(未招募)
入组人数
1,649

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

性别
All

入选标准

  • MAST-DURATION:
  • 1. Patients aged =10 years with TBI managed in an NSU who have started on phenytoin or levetiracetam due to an acute symptomatic seizure during acute hospitalisation
  • 2. 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:
  • 1. Patients aged =10 years, with TBI managed in an NSU without an acute symptomatic seizure
  • 2. 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

排除标准

  • MAST-DURATION:
  • 1. Un-survivable injury
  • 2. Previous history of epilepsy
  • 3. Patients who are on an AED pre-TBI
  • 4. Patient who has been clinically prescribed an AED to treat PTS (other than phenytoin or levetiracetam) since current admission
  • 5. Any hypersensitivity to study drug selected or any of its excipients
  • MAST-PROPHYLAXIS:
  • 1. Post-traumatic seizures
  • 2. Unsurvivable injury
  • 3. Previous history of epilepsy
  • 4. Patients who are on an AED pre-TBI
  • 5. Pregnancy or breastfeeding
  • 6. Any hypersensitivity to study drug (or hydantoins or pyrrolidone derivatives) or any of its excipients
  • 7. Time interval from the time of admission to NSU to randomisation exceeds 48 hours

研究者

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