Brain Edema XIII pp 61-64
The significance of crossovers after randomization in the STICH trial
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.
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 mm 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.
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.
KeywordsCrossover intracerebral haemorrhage surgery
Unable to display preview. Download preview PDF.
- 1.Arene NU, Fernandes H, Wilson S, Wooldridge T, Grivas AG, Deogaonkar M, Mendelow AD (1998) Intraventricular hemorrhage from spontaneous intracerebral hemorrhage and aneurismal rupture. In: von Wild KRH (ed) Pathophysiological principles and controversies in neurointensive care: minimizing mortality in head injured patients by “the Lund concept”? W. Zuckschwerdt Verlag, MunichGoogle Scholar
- 5.Mendelow AD, Gregson BA, Fernandes HM, Murray GD, Teasdale GM, Hope DT, Karimi A, Shaw MD, Barer DH; STICH investigators (2005) 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. Lancet 365: 387–397PubMedGoogle Scholar
- 7.Pocock SJ (1983) Clinical trials: a practical approach. Wiley, New York, pp 114Google Scholar