Spontaneous intracerebral haemorrhage (ICH) accounts for 10% of all cases of stroke and is common in younger patients (Bamford et al., 1990). The morbidity and mortality exceed 60% and young disabled survivors are a significant burden to both Health and Social Services with only 12% of all ICH patients emerging with minor handicap (Broderick et al., 1994).
The role of operative neurosurgical intervention is controversial and the practice continues to be haphazard (Fernandes et al., 1999; Gregson et al., 2003). Within the spectrum of ICH there are some patients (with large or space occupying ICH) who require surgery for neurological deterioration and others with small haematomas who should be managed conservatively. There is equipoise about the management of patients between these two extremes. Some patients have a penumbra of functionally impaired but potentially viable tissue around the ICH. Surgical removal of the clot may improve the function and recovery in this penumbra (Siddique et al., 2002).
STICH I The need to gain robust evidence to support clinical decision making led to the initiation of the Surgical Trial in Intracerebral Haemorrhage (STICH) funded by the MRC and the Stroke Association which was activated in 1998. STICH was a prospective randomised trial to compare early surgery with initial conservative treatment for patients with spontaneous supratentorial intracerebral haemorrhage.
A parallel group-trial design was used. Early surgery combined haematoma evacuation (within 24 hours of randomisation) with best medical treatment. Initial conservative treatment used best medical treatment although delayed evacuation was allowed if it became necessary. Analysis was on an intention-to-treat basis.
Primary Outcome Measure: 8 point Glasgow Outcome Scale sent as a postal questionnaire to patients at 6 months follow-up. From this a dichotomised prognosis-based outcome measure was used (Mendelow et al., 2003). Results: This trial was the largest to date and successfully recruited 1033 patients from 87 centres around the world. Patients were randomised to early surgery (503) or initial conservative treatment (530). Of 468 patients randomised to early surgery 26% had a favourable outcome compared to 24% of the 496 randomised to initial conservative treatment (95% CI 0.66-1.19, p=0.414). (Outcome data was unavailable for 69 patients). Interpretation: STICH suggested a small non-significant advantage for surgery (Mendelow et al., 2005). For the full results see Lancet 2005 .Justification for STICH II Detailed analysis of the CT images from STICH has shown that 42% of patients included in STICH who had assessable scans also had an associated intraventricular haemorrhage (IVH). The prognosis for patients with intraventricular haemorrhage with or without hydrocephalus is much worse than that for intracerebral haemorrhage alone. Removing these patients from the analysis and focusing on superficial haematomas presents a more encouraging picture for surgery.
There were 223 patients in STICH with such haematomas and with initial conservative treatment 37% achieved a favourable outcome using the prognosis-based outcome methodology used in STICH (Mendelow et al., 2003). By contrast 49% of patients achieved a favourable outcome with early surgery (p=0.080). Furthermore using prognosis-based Rankin as the outcome variable a significant benefit was observed for surgical patients in this subgroup. (p = 0.013). Although this is a post hoc identified subgroup, the exclusion of IVH makes clinical sense in the context of debulking surgery for lobar haematomas.
Further analysis of the subgroup of patients with lobar haematomas from the trials of Auer et al. and Teernstra et al. support the hypothesis that this subgroup might benefit from early surgery.
An unfortunate outcome of STICH I has been that many people have misinterpreted the results to argue that there is no need to operate on patients with ICH at all. To leave patients with lesions that should be removed (an unfortunate misinterpretation of STICH) would condemn such patients to non-operative treatment perhaps for evermore. Since STICH I was not powered sufficiently to answer the question about this subgroup alone there is an urgent need to undertake STICH II.
The purpose of STICH II is therefore to evaluate the role of early surgery in superficial supratentorial lobar haematomas without intraventricular haemorrhage.
Further details can be found in the study summary and the protocol.