MaST Trial

Management of Seizures after Traumatic Brain Injury

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Research summary

Traumatic brain injury (TBI) is an alteration in brain function or other evidence of brain pathology, caused by an external force. It is a major public health problem that can result in physical, cognitive, functional and psychosocial disability. The majority of patients who have a TBI do not need to stay in hospital. However, approximately 9,000 patients require admission to a specialist hospital each year in the UK, as their injury is more serious.

Post-traumatic seizures (PTS) are well recognised following TBI. They are classified as acute symptomatic or provoked (within 7 days post-TBI) or late (after 7 days). Seizures during acute hospitalisation can lead to significant derangement of brain physiology and can even lead to brain herniation and death. Additionally, PTS during acute hospitalisation have been shown to be an independent risk factor for PTS within 12 and 24 months following TBI. Late PTS within 24 months can have a negative impact on quality of life, return to work, return to driving, and can even result in death.

The overall aim of the MAST trial is to define best practice in the use of anti-epileptic drugs for patients following a traumatic brain injury. The MAST-PROPHYLAXIS trial has been designed to assess the clinical effectiveness of a short course of phenytoin or levetiracetam, used as seizure prophylaxis. Where as, the MAST-DURATION trial has been designed to determine the clinical effectiveness of a short course versus a longer course of AEDs in the prevention of further seizures. The two closely related clinical trials will be conducted, in parallel but independent of each other. The choice and duration of the trial drugs, phenytoin and levetiracetam, are reflective of a recent survey carried out in neurosurgical centres around the UK.

clinicaltrials.gov

Main inclusion criteria

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 randomisation within 48 hours of admittance.

MAST-DURATION:

  1. 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

  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

Main exclusion criteria

MAST-PROPHYLAXIS:

The presence of any of the following will preclude patient inclusion:

  1. Post-traumatic seizures

  2. Unsurvivable injury

  3. Previous history of epilepsy

  4. Patients who are taking an AED pre-TBI

  5. Pregnancy or breastfeeding

  6. Any known hypersensitivity to study drugs (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

MAST-DURATION:

The presence of any of the following will preclude patient inclusion:

  1. Unsurvivable injury

  2. Previous history of epilepsy

  3. Patients who are taking 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 known hypersensitivity to study drug selected or any of its excipients

  6. For phenytoin: known hypersensitivity to other hydantoins

  7. For levetiracetam: known hypersensitivity to other pyrrolidone derivatives

Chief investigator

Prof Peter Hutchinson

Contact details

Clinical Trials Manager: Dr Paula Kareclas

Telephone: 01223 256624 | Email: [email protected]