Kurzfassung

Spontaneous intracerebral hemorrhage (ICH) remains a devastating disease with mortality rates up to 52% at 30 days. It is a major public health problem with an annual incidence of 10-30 per 100’000 population, accounting for 2 million  (10-15%)  of  about  15  million  strokes  worldwide  each  year.  The strategy  of  decompressive  craniectomy  (DC)  is  beneficial  in  patients  with...Spontaneous intracerebral hemorrhage (ICH) remains a devastating disease with mortality rates up to 52% at 30 days. It is a major public health problem with an annual incidence of 10-30 per 100’000 population, accounting for 2 million  (10-15%)  of  about  15  million  strokes  worldwide  each  year.  The strategy  of  decompressive  craniectomy  (DC)  is  beneficial  in  patients  with malignant  middle  cerebral  artery  (MCA)  infarction.  Based  on  the  common
pathophysiological  mechanisms  of  these  two  conditions,  this  procedure  is also  frequently  performed  in  patients  with  ICH,  but  is  has  not  yet  been investigated in a randomized trial.
The  primary  objective  of  this  randomized  controlled  trial  is  to  determine whether decompressive surgery and best medical treatment in patients with spontaneous ICH will improve outcome compared to best medical treatment only. 
Secondary  objectives  are  to  analyze  mortality,  dependency  and  quality  of life. 
Safety  endpoints  are  to  determine  cause  of  any  mortality  and  the  rate  of medical  and  surgical  complications  after  DC  compared  with  best  medical treatment alone.
The primary outcome is the composite of mortality or dependency (modified Rankin Scale (mRS) 5 and 6) at 6 months.
Secondary  outcomes  are:  mortality,  alternate  dichotomy:  mRS  0-3  versus 4-6, mRS shift analysis, quality of life, in-hospital mortality, complications, the impact of patient characteristics and surgical features


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