Pharmacological Management of Seizures Post Traumatic Brain Injury (MAST)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,649
- 主要终点
- MAST-PROPHYLAXIS: Occurrence of PTS
研究概览
简要总结
The overall aim of the MAST trial is to define best practice in the use of anti-epileptic drugs (AEDs) for patients following a traumatic brain injury (TBI). The trial will consist of two parts. The first part aims to answer whether a shorter or a longer course of AEDs is better to prevent further seizures in patients who have started having seizures following TBI (MAST - duration). The second part aims to answer whether a 7-day course of either Phenytoin or Levetiracetam should be used for patients with a serious TBI to prevent seizures from starting (MAST- prophylaxis).
详细描述
The majority of patients who suffer a traumatic brain injury (TBI) do not need to stay in hospital overnight. However, some require admission to a specialist hospital, as their injury is more serious. Seizures can be harmful or even fatal, if not treated appropriately. Medications that reduce the risk of seizures are called antiepileptic drugs (AEDs). However, AEDs have side effects, which can affect patients' quality of life, memory, concentration and general health.
Patients with seizures after TBI are typically prescribed an AED to prevent further seizures, most commonly Phenytoin or Levetiracetam. Some doctors favour a short course, whereas others favour a longer course. The first part of the trial aims to answer if one approach is better than the other (MAST-duration). The second part of the trial aims to answer if a 7-day course of either Phenytoin or Levetiracetam should be used for patients with a serious TBI to prevent seizures from happening (MAST- prophylaxis).
All patients admitted to a neurosurgical unit (NSU) within the UK, with a serious TBI, will be considered for the trial. Patients who have been started on either Phenytoin or Levetiracteam by their clinical team due to seizures will be randomised to either up to 3 months or at least 6 months of treatment. In an independent, parallel trial, TBI patients who have not had a seizure will be randomised to phenytoin, levetiracetam or no treatment. All patients will be managed as per usual NHS practice and followed up for 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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.
- •Exclusion Criteria:
- •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
研究组 & 干预措施
MAST PROPHYLAXIS - Phenytoin Sodium
TBI patients, without an acute symptomatic seizure, will receive a 7-day course of Phenytoin Sodium as seizure prophylaxis.
干预措施: Phenytoin Sodium (Drug)
MAST DURATION - <3 months
TBI patients with early seizures (within first 7 days following trauma) will receive a short course of up to 3 months of either Phenytoin Sodium or Levetiracetam.
干预措施: Phenytoin Sodium (Drug)
MAST DURATION - <3 months
TBI patients with early seizures (within first 7 days following trauma) will receive a short course of up to 3 months of either Phenytoin Sodium or Levetiracetam.
干预措施: Levetiracetam (Drug)
MAST DURATION - >6 months
TBI patients with early seizures (within first 7 days following trauma) will receive a longer course of at least 6 months of either Phenytoin Sodium or Levetiracetam.
干预措施: Phenytoin Sodium (Drug)
MAST DURATION - >6 months
TBI patients with early seizures (within first 7 days following trauma) will receive a longer course of at least 6 months of either Phenytoin Sodium or Levetiracetam.
干预措施: Levetiracetam (Drug)
MAST PROPHYLAXIS - Levetiracetam
TBI patients, without an acute symptomatic seizure, will receive a 7-day course of Levetiracetam as seizure prophylaxis. Dosing will be as prescribed clinically by the treating physician.
干预措施: Levetiracetam (Drug)
结局指标
主要结局
MAST-PROPHYLAXIS: Occurrence of PTS
时间窗: Within 2 weeks post TBI
The primary outcome for MAST-PROPHYLAXIS is the occurrence of an acute symptomatic seizure. This will be assessed in the neurosurgical unit, or by telephone following discharge.
MAST-DURATION: Occurrence of late PTS
时间窗: Within 24 months post traumatic brain injury
The primary outcome for MAST-DURATION is the occurrence of late post-traumatic seizure. This will be assessed by follow-up questionnaire.
次要结局
- Both trials: Mortality(At 6, 12, 18 and 24 months)
- MAST-PROPHYLAXIS: Occurrence of post-traumatic seizures(Within 24 months post traumatic brain injury)
- Both trials: Disability(At 6, 12, 18 and 24 months)
- MAST-PROPHYLAXIS: Time to post-traumatic seizure(Within 24 months post traumatic brain injury)
- Both trials: Cognitive function(At 6, 12, 18 and 24 months)
- Both trials: Frequency of PTS(Within 24 months post traumatic brain injury)
- Both trials: Quality of life(At 6, 12, 18 and 24 months)
- Both trials: Adverse events(At 6, 12, 18 and 24 months)
- Both trials: Hospital admissions(Within 24 months post traumatic brain injury)
- Both trials: Frequency of adverse events of special interest(Up to 24 months)
研究者
Peter Hutchinson
Professor of Neurosurgery & Honorary Consultant Neurosurgeon
University of Cambridge