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Table 1 HYBERNATUS trial flow chart

From: Neuroprotective effect of therapeutic hypothermia versus standard care alone after convulsive status epilepticus: protocol of the multicentre randomised controlled trial HYBERNATUS

 

Inclusion

Day 0

Day 1

Day 2

Day 7

Day 14

Day 28

ICU discharge

Hospital discharge

Day 90 (±7 days)

Eligibility: check inclusion and non-inclusion criteria

X

      

Patient/next of kin information and consent

X

      

Randomisation (within 8 h after CSE onset)

 

X

     

Standardised anticonvulsant treatment

 

X

     

Brain imaging and other aetiological investigations

 

X

     

Therapeutic hypothermia (in the intervention group)

 

X

X

    

Core temperature monitoring (every 4 h)

 

X

X

    

Continuous EEG monitoring

 

X

X

    

30-min continuous EEG extract (centralised reading)

 

X

X

    

Clinical and laboratory monitoring

 

X

X

X

X

  

Serious adverse event reporting

 

X

X

X

X

X

X

Glasgow Outcome Scale (GOS) score evaluation

    

X

X

X1, 2

Standard EEG

      

X2

Brain MRI

      

X2

MMSE score

      

X2

FIM scale score

      

X2

Neurological evaluation

      

X2

  1. 1By phone interview in all cases
  2. 2Neurologist visit, if feasible