Spontaneous intracerebral haemorrhage (ICH) accounts for 10 to
40% of all cases of stroke
The morbidity and mortality exceed 60%.
Young disabled survivors are a significant burden to both Health
Services and family.
Within the spectrum of spontaneous intracerebral haemorrhage there
are some patients with large or space occupying haemorrhage who
require surgery for neurological deterioration .
And others with small haematomas who should be managed
There is equipoise about the management of patients between these
Findings of previous trials
The first randomised trial of Surgical Treatment of ICH, published in
But it did not show a significant advantage for either surgical or
Many other studies were done after this but none showed benefit of
one over other method of Rx.
The need to gain evidence to support clinical decision making led to
the initiation of the Surgical Trial in Intracerebral Haemorrhage
Started in 1998, this trial is the largest to date and successfully
recruited 1033 patients from 87 centres around the world.
RESULT OF STICH I
Showed a small non-significant advantage for surgery (Mendelow et
UNFORTUNATE OUTCOME OF STICH I
Had been that many people misinterpreted the
results to argue that there was no need to operate on
patients with ICH at all !
Neurosurgeons know that early removal of an intracranial
haemorrhage is highly effective in the context of trauma.
It seems unlikely that surgery would be of benefit in one scenario and
not in the other.
Hence the STICH II Trial.
Prospective, randomized, parallel group trial.
In all, 129 NSx units in 39 countries.
Only patients for whom the treating neurosurgeon is in equipoise
about the benefits of early craniotomy compared to initial conservative
treatment are eligible for the trial.
Outcome is measured at six months via a postal questionnaire
All of the following :
Evidence of a spontaneous lobar ICH on CT scan (1 cm or less from
the cortex surface of the brain)
Patient within 48 hours of ictus.
Best MOTOR score on the Glasgow Coma Scale (GCS) of 5 or 6 and
best EYE score on the GCS of 2 or more
Volume of haematoma between 10 and 100 ml [Calculated using
(a × b × c)/2 method].
Any of them :
Clear evidence that the haemorrhage is due to an aneurysm or
angiographically proven arteriovenous malformation.
Intraventricular haemorrhage of any sort.
ICH secondary to tumour or trauma.
Basal ganglia, thalamic, cerebellar or brainstem haemorrhage or
extension of a lobar haemorrhage into any of these regions
If surgery cannot be performed within 12 hours.
Patients who did not consent to participate
Patients were randomly allocated to either early surgery or initial
All patient must have an baseline CT head.
In the early surgery group, surgeons were expected to undertake
evacuation of the haematomas within 12 h.
In the initial conservative treatment group, delayed evacuation was
permitted if judged clinically appropriate.
It is not possible to blind either patients or treating surgeons to when
the patient has had surgery or whether they have had surgery.
To minimise possible sources of bias randomisation is undertaken
centrally by an independent organization.
Centre for Healthcare Randomised Trials, Aberdeen.
Randomisation must take place within 48 hours of ictus
Eligible patients randomly assigned in a 1:1 ratio to early surgery or
early medical treatment group.
Randomization done with the use of telephone and internet based
system with stratification according to country and planned operation.
STUDY END POINTS
Primary end point :
STUDY END POINTS
Secondary end point :
time to death,
prognosis-based dichotomised Rankin and GOSE, and Rankin
and EuroQol; all measured at 6 months.
Analysis will be on an “intention to treat” basis
a sample size of 566 (283 in each group) was needed to show a 12%
benefit from surgery (two-sided significance level of 0·05) with 80%
Hence a sample size of 600 patients to allow for withdrawals and
Primary outcome analysis was a simple categorical frequency
comparison by use of the χ2 test for prognosis-based favourable and
unfavourable outcome on GOSE(GLASGOW OUTCOME SCALE-EXTENDED)
Secondary analysis consisted of a Kaplan-Meier survival curve with
log-rank test, χ2 test for mortality at 6 months, and 6 month prognosis-based
The two groups were well matched at baseline,
57% of total were male and median age was 65.
50% of patient in early surgery group and 49% in early conservative
group had a GCS of 14 or 15 at the time of randomization.
Characteristics of haematomas
EARLY SURGERY GROUP CONSERVATIVE GROUP
MEDIAN 38 36
MEAN 41.4 41.0
MEDIAN 1 1
MEAN 1.6 1.6
SIDE OF H’AGE
LEFT 158 (52%) 149 (51%)
RIGHT 147 (48%) 142 (49%)
Early surgery group Early conservative group
Unfavourable 174(59%) 178(62%)
Favourable 123(41%) 108(38%)
Mortality at 6 months
Dead 54(18%) 69(24%)
Alive 244(82%) 222(76%)
Prognosis based modified Rankin
Unfavourable 155 (53%) 158 (56%)
Favourable 140 (47%) 126 (43%)
KAPLAN-MEIER SURVIVAL CURVE
Source: The Lancet 2013; 382:397-408 (DOI:10.1016/S0140-6736(13)60986-1)
DID not find significant evidence to support that early surgery
compared with initial conservative treatment (with delayed surgery if
the patient deteriorates) improves outcome in conscious patients in
whom there is a superficial intracerebral haemorrhage of 10—100 mL
and no evidence of intraventricular haemorrhage.
Strengths of the study
Prospective randomized trial.
Baseline characteristics of patients similar.
Early randomization and early surgery.
Limitations of the study
Cross over : 62 (21%) of 291 patients assigned to initial conservative
treatment went on to have delayed surgery.But because of the
intention-to-treat analysis they remained in the initial conservative
Limitations of the study
More than half of the patients had good prognosis(i.e. 66% pt inearly
surgery group and 64% pt inconsevative group)
But the patients who benefited most from surgery were poor
Was the randomization list concealed ? yes
Was the follow up of the patients sufficiently long and complete ? yes
Were the patients, clinicians and the study personnel kept “blind” to treatment ? No
Were the groups treated equally ? yes
Were the groups similar at the start of the trial ? yes
Does these results apply to our patient ? ?