title: Early surgery versus initial conservative treatment in patients with spontaneous supratentorial lobar intracerebral haematomas (STICH II): a randomised trial.
abstract: BACKGROUND
  The balance of risk and benefit from early neurosurgical intervention for conscious patients with superficial lobar intracerebral haemorrhage of 10-100 mL and no intraventricular haemorrhage admitted within 48 h of ictus is unclear. We therefore tested the hypothesis that early surgery compared with initial conservative treatment could improve outcome in these patients.
  
  
  METHODS
  In this international, parallel-group trial undertaken in 78 centres in 27 countries, we compared early surgical haematoma evacuation within 12 h of randomisation plus medical treatment with initial medical treatment alone (later evacuation was allowed if judged necessary). An automatic telephone and internet-based randomisation service was used to assign patients to surgery and initial conservative treatment in a 1:1 ratio. The trial was not masked. The primary outcome was a prognosis-based dichotomised (favourable or unfavourable) outcome of the 8 point Extended Glasgow Outcome Scale (GOSE) obtained by questionnaires posted to patients at 6 months. Analysis was by intention to treat. This trial is registered, number ISRCTN22153967.
  
  
  RESULTS
  307 of 601 patients were randomly assigned to early surgery and 294 to initial conservative treatment; 298 and 291 were followed up at 6 months, respectively; and 297 and 286 were included in the analysis, respectively. 174 (59%) of 297 patients in the early surgery group had an unfavourable outcome versus 178 (62%) of 286 patients in the initial conservative treatment group (absolute difference 3·7% [95% CI -4·3 to 11·6], odds ratio 0·86 [0·62 to 1·20]; p=0·367).
  
  
  CONCLUSIONS
  The STICH II results confirm that early surgery does not increase the rate of death or disability at 6 months and might have a small but clinically relevant survival advantage for patients with spontaneous superficial intracerebral haemorrhage without intraventricular haemorrhage.
  
  
  BACKGROUND
  UK Medical Research Council.
authors.affiliation: Newcastle University, Neurosurgical Trials Unit, Newcastle upon Tyne, UK.
authors.forename: A David
authors.initials: AD
authors.lastname: Mendelow
authors.affiliation: Newcastle University, Neurosurgical Trials Unit, Newcastle upon Tyne, UK. Electronic address: barbara.gregson@ncl.ac.uk.
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Gregson
authors.affiliation: Newcastle University, Neurosurgical Trials Unit, Newcastle upon Tyne, UK.
authors.forename: Elise N
authors.initials: EN
authors.lastname: Rowan
authors.affiliation: Edinburgh University, Centre for Population Health Sciences, Medical School, Edinburgh, UK.
authors.forename: Gordon D
authors.initials: GD
authors.lastname: Murray
authors.affiliation: Royal Victoria Infirmary, Newcastle upon Tyne, UK.
authors.forename: Anil
authors.initials: A
authors.lastname: Gholkar
authors.affiliation: Newcastle University, Neurosurgical Trials Unit, Newcastle upon Tyne, UK.
authors.forename: Patrick M
authors.initials: PM
authors.lastname: Mitchell
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002543:Cerebral Hemorrhage / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D003399:Craniotomy / Q000706:statistics & numerical data; D006233:Persons with Disabilities / Q000706:statistics & numerical data; D005260:Female; D015600:Glasgow Coma Scale; D006406:Hematoma / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D061665:Time-to-Treatment; D016896:Treatment Outcome; D055815:Young Adult