Overview

Pharmacological Management of Seizures Post Traumatic Brain Injury

Status:
Not yet recruiting
Trial end date:
2028-03-01
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Collaborator:
University of Cambridge
Treatments:
Levetiracetam
Phenytoin
Criteria
MAST DURATION

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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