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Early surgery versus initial conservative treatment in patients with spontaneous supratentorial intracerebral haematomas in the International Surgical Trial in Intracerebral Haemorrhage (STICH): a randomised trial Cerebrovascular Conference October 15, 2012. John F Morrison MD . STICH.
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Early surgery versus initial conservative treatment in patients with spontaneous supratentorialintracerebralhaematomas in the International Surgical Trial in IntracerebralHaemorrhage (STICH): a randomised trialCerebrovascular ConferenceOctober 15, 2012 John F Morrison MD
STICH • PURPOSE: Compare early surgery with conservative management • METHODS: Parallel trial with randomized grouping (early surgery vs. conservative management). Glasgow outcome scale at 6-month follow-up • RESULTS: Surgery trended towards favorable outcome, but insignificant. • CONCLUSIONS: No overall benefit from early surgery
DEMOGRAPHICS • Incidence – 2 in 10,000 • 10 – 40% of strokes • Mortality – up to 60% reported • Low functional recovery (~10% w/ minor deficit)
STICH • Inclusion criteria: • CT evidence spontaneous supratentorial ICH • Clinical uncertainty principle • Surgeon determined • ICH > 2cm • GCS > 5
STICH • Exclusion criteria • Suspicion for aneurysm or AVM • ICH from tumor/trauma • Extension in to ventricle/brain stem • Pre-existing neurological deficit • Unable to reach surgery within 24 hours
STICH • Initial 259 patients • 40% favorable outcome • 800 required for p 0.05 to show 10% benefit from surgery with a b of 0.8 • Additional 25% added for errors • Total sample size needed 1000
STICH • Intention to treat • Analysis based on initial treatment intent, not administered treatment • Outcome measurement • Poor prognosis: > “Upper severe disability” • Good prognosis: > Moderate disability
STICH • 1033 patients enrolled • 503 surgical, 530 conservative • 496 surgical patients completed • 529 conservative • 28 underwent surgery > 24 hours from ictus and were excluded • 140 in conservative management underwent surgery • 82 for neurological deterioration
STICH II • PURPOSE: Compare early surgery with conservative management in lobar hemorrhage • METHODS: Multicenter/multinational randomized control trial of ICH patients with clinical uncertainness • Currently enrolling patients
STICH II • Meta-analysis • 8 studies including 2186 cases • Outcome measurement: • GOS, Barthel Index, MRS • Unfavorable: Death, vegetative, or sever disability on GOS
STICH II - RESULTS • Improved outcome • Surgery within 8 hours (p < 0.003) • Hematoma 20 – 50 mL (p = 0.005 • GCS 9 – 12 (p = 0.0009) • Age 50 – 69 (p = 0.01)
STICH II - RESULTS • No evidence that hematomas located in the deeper regions, basal ganglia or thalamus, may benefit from surgery • There is, however, a suggestion that patients with lobar hematomas and no IVH might benefit from surgery