Therapy
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
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Summary
Posted By: George Brieva
E-Mail: jorge.Brieva@mater.health.nsw.gov.au
Posted Date: 20/01/06
Title: 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
Authors: ProfA David Mendelow, , Barbara A Gregson, Helen M Fernandes, Gordon D Murray, Graham M Teasdale, D Terence Hope, Abbas Karimi, M Donald M Shaw, David H Barer and for the STICH investigators
Reference: Lancet 2005;365:387-97
Link: Click here for a direct link to the paper. A password may be required for access to fulltext.
Abstract: Background: Spontaneous supratentorial intracerebral haemorrhage accounts for 20% of all stroke-related sudden neurological deficits, has the highest morbidity and mortality of all stroke, and the role of surgery remains controversial. We undertook a prospective randomised trial to compare early surgery with initial conservative treatment for patients with intracerebral haemorrhage.
Methods: A parallel-group trial design was used. Early surgery combined haematoma evacuation (within 24 h of randomisation) with medical treatment. Initial conservative treatment used medical treatment, although later evacuation was allowed if necessary. We used the eight-point Glasgow outcome scale obtained by postal questionnaires sent directly to patients at 6 months follow-up as the primary outcome measure. We divided the patients into good and poor prognosis groups on the basis of their clinical status at randomisation. For the good prognosis group, a favourable outcome was defined as good recovery or moderate disability on the Glasgow outcome scale. For the poor prognosis group, a favourable outcome also included the upper level of severe disability. Analysis was by intention to treat.
Findings: 1033 patients from 83 centres in 27 countries were randomised to early surgery (503) or initial conservative treatment (530). At 6 months, 51 patients were lost to follow-up, and 17 were alive with unknown status. Of 468 patients randomised to early surgery, 122 (26%) had a favourable outcome compared with 118 (24%) of 496 randomised to initial conservative treatment (odds ratio 0·89 [95% CI 0·66–1·19], p=0·414); absolute benefit 2·3% (–3·2 to 7·7), relative benefit 10% (–13 to 33).
Interpretation Patients with spontaneous supratentorial intracerebral haemorrhage in neurosurgical units show no overall benefit from early surgery when compared with initial conservative treatment.
 
Are the Results Valid?
1. Was the assignment of patients to treatments randomized? ( Was allocation concealment maintained?)
Randomization was done via a Central 24-h telephone service. Neurosurgeons completed a randomisation form after Consent and then make the phone call. The use of this approach resulted in maintenance of allocation concealment.
2. Were all patients who entered the trial properly accounted for and attributed at its conclusion?
2a. Was followup complete?
Trial profile reported
Lost of follow up: 35/503 (6%) intervention group 33/530 (6%) conservative treatment group
2b. Were patients analyzed in the groups to which they were randomized?
Yes, Analysis done on an intension-to-treat basis
3. Were patients, health workers, and study personnel blind to treatment?
No, but assessment of disabilities done independently from neurosurgeons
4. Were the groups similar at the start of the trial?
While the groups seem similar in baseline characteristics, There is not p values provided. The investigators mention “well matched” baseline groups.
5. Aside from the experimental intervention, were the groups treated equally?
Yes
What are the Results?
1. How large was the treatment effect?
Sample size of 800 needed to detect a 10% absolute benefit from surgery with an 80% power. A safety margin of 25% was built . Final sample 1000.
However in view of a Negative trial, is commonly accepted that the power of a clinical trial should approach 90%.
Primary favourable outcome: 122(26%) vs 118(24%)
Absolute benefit of early surgery: 2%
relative risk reduction: 10%
Mortality rate: 36% vs 37%. Absolute benefit 1.2% and relative benefit: 2% Ranking Scale: 152(33%) vs 137(28%). Absolute benefit 4.7%. Relative benefit: 17% Brathel Index: 124(27%) vs 110(23%) Absolute benefit 4.1%. Relative benefit 18% It is important to mention that there is a trend to overestimate the true benefit when following relative risk reductions
2. How precise was the estimate of the treatment effect?
Confidence intervals presented
Primary outcome: ARR 2.3% (-3.2 – 7.7)
Will the Results Help Me In Caring For My Patients?
1. Can the results be applied to my patient care?
It seems that for patients with a GCS more than 5 and in the presence of an acute hemorrhagic stroke,and excluding trauma and SAH, other treatment options (novoseven?) and conservative support should be offered instead of neurosurgery
2. Were all clinically important outcomes considered?
The outcomes considered are clinically meaningful because are related to survival and disability assessed by Ranking Scale, Brathel Index and Glasgow outcome scale. And also because it divided the patients with a good or poor prognosis at randomization based on the clinical status.
3. Are the likely treatment benefits worth the potential harms and costs?
Interestingly there were no difference in the total cost between groups

What other people had to say about:
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

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