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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
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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
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DEMOGRAPHICS Incidence – 2 in 10,000 10 – 40% of strokes Mortality – up to 60% reported Low functional recovery (~10% w/ minor deficit)
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STICH Inclusion criteria: – CT evidence spontaneous supratentorial ICH – Clinical uncertainty principle Surgeon determined – ICH > 2cm – GCS > 5
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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
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STICH Initial 259 patients – 40% favorable outcome – 800 required for p 0.05 to show 10% benefit from surgery with a of 0.8 – Additional 25% added for errors Total sample size needed 1000
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STICH Intention to treat – Analysis based on initial treatment intent, not administered treatment Outcome measurement – Poor prognosis: > “Upper severe disability” – Good prognosis: > Moderate disability
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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
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STICH Crossover (140) Control (390) p 65%Male55%0.04 58%Clot > 50 mL27%0.0001 73%Superficial/cortical46%0.0001 51%Lobar37%0.0001
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STICH
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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
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STICH II
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Meta-analysis – 8 studies including 2186 cases – Outcome measurement: GOS, Barthel Index, MRS Unfavorable: Death, vegetative, or sever disability on GOS
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STICH II - LOCATION
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STICH II – LOCATION (cont.)
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STICH II - TIMING
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STICH II - VOLUME
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STICH II - GCS
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STICH II - AGE
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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)
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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
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