Treatment of established status epilepticus in the elderly - a study protocol for a prospective multicenter double-blind comparative effectiveness trial (ToSEE)

Table 1 Visit schedule with all corresponding assessments

Visit	Screening	V1					V2^a
		Initiation of infusion				During 24 h after T0	Further Hospital stay
		T0	T15	T30	T60	During 24 h after T0	Further Hospital stay
Time		0	15 min	30 min	60 min	24 h
Eligibility criteria	X
Informed consent^b	X
Randomization	X
Medical/Medication History	X
CP-Monitoring^c		Continuously
EEG^d	X⁴	Continuously⁴
Blood analysis^e	X				X
VPA or LEV infusion		X
GCS^f	X		X	X	X		X
Neurological exam	X				X		X
mRS/BI^g	X^h						X
Home care	X^h						Xⁱ
Adverse events		X
Recurrence seizures/SE		Recorded any time until discharge
Clinical data^j		X

VPA Valproate, LEV Levetiracetam, (NC)SE (nonconvulsive) status epilepticus
^aFollow-up-visit, at day of discharge or day 30
^bby legal or authorised representative or according to §41 AMG (1)
^ccardiopulmonary monitoring
^delectroencephalography, only in patients with NCSE
^ecomplete blood count, liver, kidney function, sodium, level of VPA, level of LEV
^fGlasgow Coma Scale
^gmodified Rankin Scale/Barthel Index
^hpremorbid state by patient (retrospective) or relatives
ⁱ after hospital stay (if applicable)
^jclinical data about the hospital stay, i.e. infections with i.v. antibiotics, special medications, initiation of invasive/noninvasive ventilation, recorded on day of discharge/day 30

ISSN: 1471-2377