Surgeons and strokes….

Mendelow AD, Gregson BA, Fernandes HM et al. 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. The Lancet 2005; 365: 387-397.

RHH Journal Club. May 17th, 2012. Dr Olena Mateszko

No free full-text available

For patients with spontaneous supratentorial intracerebral haemorrhage early operative haematoma evacuation (within 24 hours of randomisation) there is no statistically significant increase in favourable outcome when compared to initial conservative treatment.

Study design:

– Outcome benefit and cost analysis

– Multicentre

– Prospective randomised controlled trial

Methodology:

Population

– 1033 adults patients enrolled over 8 years (1995-2003) from 83 centres in 27 countries

– CT evidence of a spontaneous supratentorial intracerebral haemorrhage within 72 hours where surgeon uncertain about benefits of either treatment.  Minimum haematoma diameter of 2 cm and GCS ≥ 5

– Excluded if: Underlying cause was aneurysm, AVM, tumour, trauma.  Cerebellar haemorrhage.  Extension of haemorrhage to involve brainstem.  Severe pre-existing physical/mental disability/comorbidity that may interefere with assessment of outcome.  Surgery not possible within 24 hours of randomisation. (However in 6% of early surgery group had surgery after 24 hours and were included in analysis)

Intervention

– Haematoma evacuation within 24 hours of randomization by the method of choice of the Neurosurgeon combined with appropriate and best medical treatment

Control

– No specific protocol, ‘best medical treatment’.  Later evacuation allowed if necessary

Outcomes

Primary – Death or Disability (extended GCS) at 6 months follow up

Secondary – Mortality and Disability (Barthel index, modified Rankin scale)

Validity:

– Independent central randomisation service allocated by minimisation (but later re-programmed)

– Minimisation algorithm based on side of haematoma and depth from cortical surface

– Intention to treat analysis

– Similar prognostic score and percentage good prognosis between groups

– Blinding to treatment not possible but 6/12 follow-up by postal questionnaires and without Neurosurgical involvement so researchers blinded to treatment group

– Losses to follow-up balanced between groups

Results:

– 26% of patients survived with a favourable outcome in the early surgery group vs. 24% in the initial conservative management group (p=0.414)

– Survival during first 6/12 did not significantly differ between groups (p=0.678)

Conclusions/In Practice:

– Patients with spontaneous supratentorial intracerebral haemorrhage in Neurosurgical units show no overall benefit from early surgery when compared with initial conservative management

– Nearly all patients with GCS 8 or less on presentation had unfavourable outcomes

– Potential benefit in those with superficial haemorrhage (significant in sub-group analysis only)

– Early surgery costs are less than initial conservative management costs and not related to an increase in mortality (not significant)