Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Peter Hutchinson
+44 (0)1223 336946
pjah2@cam.ac.uk


Dr Samantha Lawes
+44 (0)1223 256624
samantha.lawes@addenbrookes.nhs.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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Be Part of Research - Trial Details - Comparing anti-epileptic treatments for seizures following traumatic brain injury

Comparing anti-epileptic treatments for seizures following traumatic brain injury

Medical Conditions

Post-traumatic seizures in traumatic brain injury patients


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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 anti-epileptic 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 study aims to answer if one approach is better than the other (MAST-DURATION). The second part of the study 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).

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

05 Mar 2021 01 Mar 2024

MAST-DURATION:
Patients will be randomly allocated to receive to a maximum of 3 months or a minimum of 6 months course of phenytoin or levetiracetam.
MAST-PROPHYLAXIS:
Patients will be randomly allocated to receive either phenytoin, levetiracetam or no anti-epileptic drug for a period of 7 days.
Current international guidelines for traumatic brain injury recommend the use of phenytoin for the prevention of early post-traumatic seizures, when the benefits are thought to outweigh the risks. In practice, alternative anti-epileptic drugs such as levetiracetam are being used clinically as they are associated with fewer risks.
Patients will be assessed for seizures during hospital admission and will also be asked to complete follow-up questionnaires at 6,12, 18 and 24 months.


MAST-DURATION:
Patients aged 10 and over, with a traumatic brain injury, managed in a neurosurgical unit, who have started on phenytoin or levetiracetam due to an acute symptomatic seizure during acute hospitalisation.
MAST-PROPHYLAXIS:
Patients aged 10 and over, with a traumatic brain injury, managed in a neurosurgical unit, without an acute symptomatic seizure.

You can take part if:



You may not be able to take part if:


MAST-DURATION: 1. Un-survivable injury2. Previous history of epilepsy3. Patients who are on an AED pre-TBI4. Patient who has been clinically prescribed an AED to treat PTS (other than phenytoin or levetiracetam) since current admission5. Any hypersensitivity to study drug selected or any of its excipients

MAST-PROPHYLAXIS:1. Post-traumatic seizures2. Unsurvivable injury3. Previous history of epilepsy4. Patients who are on an AED pre-TBI5. Pregnancy or breastfeeding6. Any hypersensitivity to study drug (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


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • NHS Lothian
    Waverley Gate 2-4 Waterloo Place
    Edinburgh
    EH1 3EG
  • University Hospitals of North Midlands NHS Trust
    Newcastle Road
    Stoke-on-trent
    ST4 6QG
  • Southmead Hospital
    Southmead Road Westbury-on-trym
    Bristol
    BS10 5NB
  • Freeman Hospital
    Freeman Road High Heaton
    Newcastle upon Tyne
    NE7 7DN
  • NHS Grampian
    Summerfield House 2 Eday Road
    Aberdeen
    AB15 6RE
  • Royal Sussex County Hospital
    Eastern Road
    Brighton
    BN2 5BE
  • NHS Tayside
    Kings Croos Clepington Road
    Dundee
    DD3 8EA
  • John Radcliffe Hospital
    Headley Way Headington
    Oxford
    OX3 9DU
  • Southampton General Hospital
    Tremona Road
    Southampton
    SO16 6YD
  • Addenbrookes Hospital
    Cambridge University Hospitals NHS Foundation Trust Hills Road
    Cambridge
    CB2 0QQ
  • Derriford Hospital
    Derriford Road
    Plymouth
    PL6 8DH
  • Royal Preston Hospital
    Sharoe Green Lane Fulwood
    Preston
    PR2 9HT
  • Queen Elizabeth Hospital
    Mindelsohn Way Edgbaston
    Birmingham
    B15 2GW
  • Walsgrave General Hospital
    Clifford Bridge Road
    Coventry
    CV2 2DX
  • Queens Medical Centre
    Derby Road
    Nottingham
    NG7 2UH
  • St. Mary's Hospital
    The Bays South Wharf Road
    London
    W2 1BL
  • James Cook University Hospital
    Marton Road
    Middlesbrough
    TS4 3BW
  • Northern General Hospital
    Herries Road
    Sheffield
    S5 7AU
  • University Hospital Aintree
    Lower Lane
    Liverpool
    L9 7AL
  • St. James's University Hospital
    Beckett Street
    Leeds
    LS9 7TF
  • NHS Greater Glasgow and Clyde
    1055 Great Western Road
    Glasgow
    G12 0XH
  • Cardiff & Vale University LHB
    Heath Park
    Cardiff
    CF14 4XW
  • St George's Hospital
    Blackshaw Road Tooting
    London
    SW17 0QT
  • The Royal London Hospital
    Whitechapel
    London
    E1 1BB
  • Hull Royal Infirmary
    Anlaby Road
    Hull
    HU3 2JZ
  • Salford Royal
    Stott Lane
    Salford
    M6 8HD
  • King's College Hospital
    Denmark Hill
    London
    SE5 9RS
  • Queens Hospital
    Rom Valley Way
    Romford
    RM7 0AG
  • Belfast City Hospital
    Lisburn Road
    Belfast
    BT9 7AB

MAST-DURATION:
The study drugs patients will be provided with are standard anti-epileptic drugs, used to control seizures. The researchers expect seizures to be reduced as a result of taking the study drug.
MAST-PROPHYLAXIS:
There is no guarantee that patients will benefit from taking part in this trial.
Apart from the potential side effects from the study drugs, there are no additional risks or disadvantages involved with taking part in this study. Patients will continue to receive the standard care for their condition.

Dr Samantha Lawes
+44 (0)1223 256624
samantha.lawes@addenbrookes.nhs.uk


Prof Peter Hutchinson
+44 (0)1223 336946
pjah2@cam.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Cambridge University Hospitals NHS Foundation Trust; University of Cambridge and funded by National Institute for Health Research.




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Read full details for Trial ID: ISRCTN13200656

Or CPMS 46732

Last updated 09 March 2021

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