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Historical Reference Page

This is a historical reference page. This trial preceded the modern evidence base. It is presented as a predecessor reference. See ENRICH (2024) for the modern successor trial that established minimally invasive evacuation for selected lobar intracerebral hemorrhage.

STICH II Trial: Surgical Treatment of Intracerebral Hemorrhage II: Superficial Lobar ICH

In patients with spontaneous superficial lobar intracerebral hemorrhage (10–100 mL, within 1 cm of cortex), does early surgical evacuation improve 6-month functional outcome compared with initial best medical management?

Mendelow et al. (Lancet 2013) · doi:10.1016/S0140-6736(13)60986-1 · 601 patients

Population

Included

  • Spontaneous lobar ICH confirmed on CT
  • Hematoma volume 10 to 100 mL
  • Hematoma within 1 cm of the cortical surface (superficial lobar)
  • No intraventricular hemorrhage
  • GCS 5 or greater at enrollment
  • Surgeon uncertain whether surgery or conservative management was better

Excluded

  • Deep ICH (basal ganglia, thalamus, internal capsule)
  • Posterior fossa hemorrhage
  • Intraventricular extension
  • ICH secondary to identified cause (AVM, aneurysm, tumor)
  • GCS 3 or 4 (catastrophic presentation)
  • Significant pre-stroke disability

Primary Outcome — Unfavorable Outcome at 6 Months

601 patients; early craniotomy vs initial conservative management; superficial lobar ICH

In 601 patients with spontaneous superficial lobar ICH (10–100 mL, within 1 cm of the cortical surface, no intraventricular extension) enrolled using equipoise-based randomization, early surgical evacuation did not significantly reduce unfavorable functional outcome at 6 months. Unfavorable outcome occurred in 59% (174 of 307) of the surgical group versus 62% (178 of 286) of the conservative group (OR 0.86, 95% CI 0.62 to 1.20, P=0.367). The STICH I lobar subgroup signal was not confirmed in this dedicated, adequately powered trial.

OR (unfavorable outcome)0.86
95% CI0.62 to 1.20
ResultNot significant (P=0.367)

Visualization not shown for predecessor reference pages. See source paper for figures.

Trial Design

STICH II was designed based on the STICH I post-hoc finding that lobar ICH within 1 cm of the cortical surface might benefit from early surgery. The trial enrolled patients with spontaneous superficial lobar ICH (10–100 mL, within 1 cm of cortex, no intraventricular extension, GCS 5 or greater) using the same equipoise-based design as STICH I. Early surgery was required within 12 hours of randomization and was predominantly craniotomy. The conservative arm allowed delayed surgery if the patient deteriorated; 21% of initially conservative patients ultimately required surgery. The primary outcome was a prognosis-adjusted endpoint: favorable or unfavorable outcome at 6 months.

Safety

Mortality at 6 months was 18% in the surgical group versus 24% in the conservative group (not statistically significant). Surgical complications and rebleeding were not significantly different between groups. The surgical arm had more early procedure-related events but achieved numerically lower mortality; neither difference was statistically significant.

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