MAST Trial
Research type
Research Study
Full title
Pharmacological management of seizures post traumatic brain injury (MAST)
IRAS ID
276415
Contact name
Peter Hutchinson
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and The University of Cambridge
Eudract number
2020-000282-16
ISRCTN Number
ISRCTN13200656
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
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 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. The main outcome measure will be the occurrence of seizures following TBI at 2 weeks in the MAST- prophylaxis trial and at 24 months in the MAST-duration trial. Finally we will be using several questionnaires to measure frequency of seizures, adverse events, neurological symptoms, quality of life, independence and disability.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
20/EE/0252
Date of REC Opinion
11 Jan 2021
REC opinion
Further Information Favourable Opinion