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 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

Crossover (140)

Control (390)

p

65% Male 55% 0.0458% Clot > 50 mL 27% 0.000173% Superficial/cortical 46% 0.000151% Lobar 37% 0.0001

STICH

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

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 - LOCATION

STICH II – LOCATION (cont.)

STICH II - TIMING

STICH II - VOLUME

STICH II - GCS

STICH II - AGE

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