- Surgical + Peri-operative Care
- Trials in setup
Defining best practice in the use of Anti-epileptic drugs for adult traumatic brain injury patients
The majority of patients who suffer a traumatic brain injury (TBI), from, for example, road accidents, falls, assaults or sports do not need to stay in hospital overnight. However, approximately 9,000 patients require admission to a specialist hospital each year in the UK, as their injury is more serious (1). Seizures are a significant complication of TBI. Seizures can be harmful and in the worst case fatal if not treated appropriately. Medications that reduce the risk of seizures are called antiepileptic drugs (AEDs). However, AEDs have side effects, which if severe, can affect patients' quality of life, memory, concentration and general health.
Patients with seizures after TBI are typically started on a course of AED to prevent further seizures. Some doctors favour a short course of AEDs, whereas others favour a longer course. The first part of the trial aims to answer if one approach is better than the other. The second part of the trial aims to answer if a 7-day course of an AED should be used for patients with a serious TBI to prevent seizures from happening. We recently undertook a survey and half of the doctors who replied favour this approach, while half do not (due to concerns about the side effects of AEDs).
The variation in the current practice of AED prescribing is due to the lack of high-quality evidence. The project comprises of two studies running side by side that will help to define best practice in the use of AEDs for patients with serious TBI. All patients admitted to a participating hospital with a serious TBI will be considered for the trial based on pre-specified criteria. Following consent, patients who have been started on an AED by their clinical team due to seizures will be randomly placed into one of two groups of study A. One group will continue receiving AED for up to 3 months, and the other for at least 6 months. Patients who have not had a seizure will be randomly placed into one of three groups of study B. One group will receive one type of AED for seven days (phenytoin), another will receive a second type of AED for seven days (levetiracetam), and the third group will not receive an AED. All patients will be managed as per usual NHS practice and followed up for 24 months. Outcome measures will focus on the occurrence of seizures, activities of daily living, memory, concentration, quality of life, and side effects. We will also undertake a health economic analysis. We will begin with a pilot phase (50 patients in study A and 130 in study B), and if the pilot is successful, we will roll out the substantive study across the NHS (total 428 patients in study A and 1221 in study B in 25 NSUs).
Funders and sponsors
Funder: National Institute for Health Research
Sponsors: University of Cambridge, Cambridge University Hospitals NHS Foundation Trust
Prof Peter Hutchinson