Abstract 29: The Surgical Trial in Lobar Intracerebral Haemorrhage - Analysis of Crossover Patients

Abstract

Background: STICH II was an international multicentre pragmatic randomised parallel group trial to establish whether a policy of early surgery (ES) improved outcome compared to a policy of initial conservative treatment (ICT) for patients with superficial lobar intracerebral haemorrhage (ICH). The results of the “intention to treat analysis” have been published and showed a non-significant trend in favour of early surgery. However, as observed in other surgical trials, there was a substantial crossover of patients from the ICT group with 21% having surgery within 14 days of randomisation. This paper investigates these patients and their effect on outcome. Methods: Patients from the ICT group who underwent surgery within 14 days were identified and compared with patients who continued to receive conservative treatment and with patients randomised to ES. The protocol defined “early surgery” as within 12 hours of randomisation so analyses were also conducted using this definition. Per protocol and treatment received analyses were conducted. Results: For this analysis there are 285 ICT patients with outcome assessed, 233 had no surgery and 62 patients had surgery within 2 weeks: 23 within 12 hours. Of 297 patients randomised to ES, 278 had surgery within 12 hours. Surgical ICT patients had lower GCS (13 v 14) and larger volumes (54ml v 32ml) of haematoma at randomisation (p<0.0001) than non-surgical ICT. They also showed lower GCS and larger volumes (54ml v 40ml) than per protocol ES patients. Surgical ICT patients were much more likely to have an unfavourable outcome than non-surgical (84% v 63%, p < 0.002). If the surgery was after 12 hours the unfavourable outcome was higher (89%). There were no differences in outcome between per protocol ES and non-surgical ICT but there were major differences in baseline measures between these patients. Death rates were highest in ICT patients having surgery within 12 hours (48%) compared with later surgery (31%), non-surgical ICT patients (20%) and ES patients (17%). Conclusions: Patients randomised to conservative treatment who deteriorate and have surgery differ considerably from those that do not deteriorate and from those who are randomised to early surgery. Further work is needed to develop ways of analysing these data.