The significance of crossovers after randomization in the STICH trial

Prasad, KSM; Gregson, BA; Bhattathiri, PS; Mitchell, P; Mendelow, AD

doi:10.1007/3-211-30714-1_15

The significance of crossovers after randomization in the STICH trial

Lookup NU author(s): Dr Barbara Gregson, Parameswaran Bhattathiri, Patrick Mitchell, Emeritus Professor David Mendelow

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Abstract

Introduction. Of all forms of stroke, spontaneous intracerebral haemorrhage (ICH) causes the highest morbidity and mortality. The Surgical Trial in Intracerebral Haemorrhage (STICH) found no difference in outcomes between patients randomized to surgical or conservative treatment. Patients and methods. Of 530 patients randomized to initial conservative treatment, 140 crossed over to surgery. This study examines the variables associated with crossover. Results. Dominant features of the crossover group were: male, (p = 0.04), right-sided clot (p = 0.03), lobar clot (p = 0.003), clot volume (median 64 mL for crossovers vs. 38 mL for others, p < 0.00001), midline shift (median 6 rum for crossovers vs. 3 mm for others, p < 0.00001), superficial clot (median 1.3 mm for cross-overs vs. 11.5 mm for others, p < 0.00001), and randomization within 12 hours of ictus (p < 0.0005). Thalamic location (p = 0.002) was under-represented. Intraventricular haemorrhage, hydrocephalus, and focal deficits were not associated with crossover. Craniotomy was the method of evacuation in 85% of crossover patients. Conclusions. Crossover to surgery was more likely when ICH had these features: Right side, lobar location, superficial, large volume, big shift, and early randomization. Crossovers formed a worse prognostic group compared to non-crossovers. Surgery did not affect trial results, which were analyzed by intention-to-treat.