Pharmacological Management of Seizures Post Traumatic Brain Injury

Официальное название

Pharmacological Management of Seizures Post Traumatic Brain Injury (MAST)

Обзор

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).

Подробное описание

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.

Вмешательства

• Препарат Phenytoin Sodium
  Dosing will be as prescribed clinically by the treating physician. Phenytoin Sodium may be administered orally, intravenously or via nasogastric tube.
• Препарат Levetiracetam
  Dosing will be as prescribed clinically by the treating physician.Levetiracetam may be administered orally, intravenously or via nasogastric tube.

Первичные конечные точки

• MAST-DURATION: Occurrence of late PTS [Срок оценки: Within 24 months post traumatic brain injury]
• MAST-PROPHYLAXIS: Occurrence of PTS [Срок оценки: Within 2 weeks post TBI]

Вторичные конечные точки (10)

• MAST-PROPHYLAXIS: Occurrence of post-traumatic seizures [Срок оценки: Within 24 months post traumatic brain injury]
• MAST-PROPHYLAXIS: Time to post-traumatic seizure [Срок оценки: Within 24 months post traumatic brain injury]
• Both trials: Disability [Срок оценки: At 6, 12, 18 and 24 months]
• Both trials: Cognitive function [Срок оценки: At 6, 12, 18 and 24 months]
• Both trials: Quality of life [Срок оценки: At 6, 12, 18 and 24 months]
• Both trials: Adverse events [Срок оценки: At 6, 12, 18 and 24 months]
• Both trials: Hospital admissions [Срок оценки: Within 24 months post traumatic brain injury]
• Both trials: Frequency of PTS [Срок оценки: Within 24 months post traumatic brain injury]
• Both trials: Mortality [Срок оценки: At 6, 12, 18 and 24 months]
• Both trials: Frequency of adverse events of special interest [Срок оценки: Up to 24 months]

Критерии участия

MAST DURATION

Критерии включения

• 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

Критерии исключения

• 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

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT04573803 · A095460

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗