Eligibility

Local study conflicts

• To be updated

Inclusion Criteria:

• MAST-PROPHYLAXIS:
• Patients aged ≥10 years, with TBI managed in a neurosurgical unit 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 randomisation within 48 hours of admittance.



• MAST-DURATION:
• Patients aged ≥10 years with TBI managed in a neurosurgical unit who have started on 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

Exclusion Criteria:

• MAST-PROPHYLAXIS:
• Post-traumatic seizures
• Unsurvivable injury
• Previous history of epilepsy
• Patients who are taking an AED pre-TBI
• Pregnancy or breastfeeding
• Any known hypersensitivity to study drugs (or hydantoins or pyrrolidone derivatives) or any of its excipients
• Time interval from the time of admission to NSU to randomisation exceeds 48 hours



• MAST-DURATION:
• Unsurvivable injury
• Previous history of epilepsy
• Patients who are taking an AED pre-TBI
• Patient who has been clinically prescribed an AED to treat PTS (other than phenytoin or levetiracetam since current admission
• Any known hypersensitivity to study drug selected or any of its excipients
• For phenytoin: known hypersensitivity to other hydantoins
• For levetiracetam: known hypersensitivity to other pyrrolidone derivatives

If the patient is eligible:

• Inform the patient that they may be eligible for a research study
• Gain verbal agreement in principle before proceeding. Explain:
• Taking part in research is likely to improve the quality of their care
• Risks are carefully controlled - research is safe
• Explain the uncertainty that exists with respect to treatment of their condition
• If they change their mind they can withdraw their participation at any point

Step-by-Step Guide to Recruitment:

In standard working hours

• The team aims to be available 8am-4pm Monday to Friday;
• In research team working hours (If research team member is available, they will be signed in on alertive).
• Contact them via Ed research on alertive or extension 1041.

When the ED Research team is not available:

Page awaiting construction below

Links for further information:

Link to trial site

Link to trial site