Visit | Screening | V1 | V2a | ||||
---|---|---|---|---|---|---|---|
 | Initiation of infusion |  |  |  | During 24 h after T0 | Further Hospital stay | |
T0 | T15 | T30 | T60 | ||||
Time |  | 0 | 15 min | 30 min | 60 min | 24 h |  |
Eligibility criteria | X | Â | Â | Â | Â | Â | Â |
Informed consentb | X | Â | Â | Â | Â | Â | Â |
Randomization | X | Â | Â | Â | Â | Â | Â |
Medical/Medication History | X | Â | Â | Â | Â | Â | Â |
CP-Monitoringc | Â | Continuously | Â | Â | |||
EEGd | X4 | Continuously4 | Â | Â | |||
Blood analysise | X | Â | Â | Â | X | Â | Â |
VPA or LEV infusion | Â | X | Â | Â | Â | Â | Â |
GCSf | X | Â | X | X | X | Â | X |
Neurological exam | X | Â | Â | Â | X | Â | X |
mRS/BIg | Xh | Â | Â | Â | Â | Â | X |
Home care | Xh | Â | Â | Â | Â | Â | Xi |
Adverse events | Â | X | Â | ||||
Recurrence seizures/SE | Â | Recorded any time until discharge | Â | ||||
Clinical dataj | Â | X | Â |