Pharmacological management of seizures post traumatic brain injury (MAST) - MAST Trial

Cambridge University Hospitals NHS Foundation Trust and The University of Cambridge0 个研究点目标入组 1,649 人开始时间: 2020年10月14日最近更新: 2020年11月16日

试验速览

暂无简介。

•MAST-PROPHYLAXIS:
•1. Patients aged aged =10 years with acute TBI managed in NSU without an acute 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 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
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1349
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•MAST-PROPHYLAXIS:
•1. Post-traumatic seizures
•2. Un-survivable 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 their excipients
•7. Time interval from the time of admission to NSU to randomisation exceeds 48 hours
•MAST DURATION
•1. Un-survivable injury
•2. Previous history of epilepsy
•3. Patients who are on 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 hypersensitivity to study drug selected or any of its excipients

发起方

Cambridge University Hospitals NHS Foundation Trust and The University of Cambridge