Early surgery versus initial conservative treatment in patients with spontaneous supratentorial lobar intracerebral haematomas (STICH II): a randomised trial

Abstract

Background: The balance of risk and benefit from early neurosurgical intervention for conscious patients with superficial lobar intracerebral haemorrhage of 10-100 mL and no intraventricular haemorrhage admitted within 48 h of ictus is unclear. We therefore tested the hypothesis that early surgery compared with initial conservative treatment could improve outcome in these patients.

Methods: In this international, parallel-group trial undertaken in 78 centres in 27 countries, we compared early surgical haematoma evacuation within 12 h of randomisation plus medical treatment with initial medical treatment alone (later evacuation was allowed if judged necessary). An automatic telephone and internet-based randomisation service was used to assign patients to surgery and initial conservative treatment in a 1:1 ratio. The trial was not masked. The primary outcome was a prognosis-based dichotomised (favourable or unfavourable) outcome of the 8 point Extended Glasgow Outcome Scale (GOSE) obtained by questionnaires posted to patients at 6 months. Analysis was by intention to treat. This trial is registered, number ISRCTN22153967.

Findings: 307 of 601 patients were randomly assigned to early surgery and 294 to initial conservative treatment; 298 and 291 were followed up at 6 months, respectively; and 297 and 286 were included in the analysis, respectively. 174 (59%) of 297 patients in the early surgery group had an unfavourable outcome versus 178 (62%) of 286 patients in the initial conservative treatment group (absolute difference 3·7% [95% CI -4·3 to 11·6], odds ratio 0·86 [0·62 to 1·20]; p=0·367).

Interpretation: The STICH II results confirm that early surgery does not increase the rate of death or disability at 6 months and might have a small but clinically relevant survival advantage for patients with spontaneous superficial intracerebral haemorrhage without intraventricular haemorrhage.

Funding: UK Medical Research Council.

Figure 1

Trial profile *One site recruited one patient but had undertaken surgery before randomisation (the patient was allocated to initial conservative treatment); another site recruited three patients, and two of these had surgery before randomisation (one allocated to early surgery and one to initial conservative treatment); because of the severe breach of protocol all four patients were excluded.

Figure 2

Kaplan–Meier survival curve

Figure 3

Extended Glasgow Outcome Scale at 6 months Proportional odds model p=0·075.

Figure 4

Subgroup analysis Forest plot GCS=Glasgow Coma Score.

Figure 5

Updated meta-analysis of 15 trials of surgery in patients with intracerebral haemorrhage (A) and individual patient data in cases of lobar haematomas without intraventricular haemorrhage (B) Data are n/N, unless otherwise indicated. Reported outcomes were unfavourable outcome in (A) and death or disability in (B). df=degrees of freedom.