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

Mendelow, A. D.; Gregson, Barbara; Fernandes, Hilda; Murray, Gordon D.; Teasdale, Graham M.; Hope, Daniel; Karimi, Abbasali; Shaw, M. D. M.; Barer, David

doi:10.1016/s0140-6736(05)17826-x

Cited by 1,028 publications

(764 citation statements)

References 30 publications

Supporting

Mentioning

707

Contrasting

Unclassified

Order By: Relevance

“…These patients are probably the most beneficed, at least in terms of early mortality, by the evacuation of the clot through a craniotomy. Disappointingly, in these comatose patients (GCS<9) sever disability is expected after ICH as was reported on the STICH 15 . In the remaining GCS subgroups (patients with GCS on admission between 9 and 15) mortality is lower and there is also a trend that favour surgery on these cases.…”

Section: Early Mortality In Spontaneous Supratentorial Intracerebralmentioning

confidence: 79%

“…Despite the data available from well designed studies, especially from the Surgical Trial in Intracerebral Haemorrhage (STICH), there is incertitude about which is the proper treatment in a particular patient with spontaneous supratentorial intracerebral haemorrhage 3,6,8,15,16,17,18,19,21,22 . The variability among patients, as well as the great number of factors that influence their outcome, are important issues to take into account.…”

Section: Discussionmentioning

confidence: 99%

“…It is estimated that this condition affects 10-20 in 100 000 people every year with a mortality between 23-58% 1,13,20,21 . Additionally, only one of five of the survivors regain functional independence at 6 months after ictus 3,13,14,15,20 . There is no definitive evidence to guide treatment but recommendations 15,16,20 .…”

Section: Introductionmentioning

confidence: 96%

“…Additionally, only one of five of the survivors regain functional independence at 6 months after ictus 3,13,14,15,20 . There is no definitive evidence to guide treatment but recommendations 15,16,20 . As a consequence, controversy regarding the possible benefit of surgery on these patients persists and thus, there is a considerable variability in the management of this type of stroke 2,16 .…”

Section: Introductionmentioning

confidence: 96%

See 3 more Smart Citations

Early mortality in spontaneous supratentorial intracerebral haemorrhage

et al. 2010

View full text Add to dashboard Cite

SummaryBackground. Spontaneous supratentorial intracerebral haemorrhage is a severe, frequent, and poorly understood condition. Despite the publication of 12 randomised controlled trials on this subject, the role of surgery remains controversial and no treatment has proved to be effective. We report on a ten year prospective cohort study based on a defined population treated with or without surgery and their outcome in terms of early survival.Methods. Population based, ten year prospective observational study directed to patients consecutively admitted to the Intensive Care Unit (ICU) in a tertiary centre with spontaneous supratentorial intracerebral haemorrhage. Patients were distributed in five groups according to the Glasgow Coma Score (GCS) at admission. Haemorrhages were classified as deep-seated or superficial. All patient received standard medical care, and additionally surgery if it was found indicated by the duty neurosurgeon. Primary endpoint was early mortality defined as dead occurred by any cause during the admission in the ICU.Findings. During the ten year period, 1.485 patients were admitted to our centre with primary intracerebral haemorrhage. Of these, 376 were admitted to the intensive care unit and 285 sustained supratentorial haemorrhages. Low GCS was strong predictor of early mortality. Despite the larger size of haematomas in patients undergoing surgical evacuation, surgery was associated with lower early mortality in all GCS subgroups. Maximal benefit was observed in patient with admission GCS of 4-8. Superficial haematomas were operated on more often, and were associated with lower mortality rate than deep-seated cases.Conclusions. Our findings suggest that craniotomy for haematoma evacuation may reduce early mortality in patients with primary supratentorial intracerebral haemorrhage. Surgery seems specially useful in patients with admission GCS between 4 and 8, and in those with superficial haemorrhages.

show abstract

Section: Early Mortality In Spontaneous Supratentorial Intracerebralmentioning

confidence: 79%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 96%

Section: Introductionmentioning

confidence: 96%

See 2 more Smart Citations

Early mortality in spontaneous supratentorial intracerebral haemorrhage

et al. 2010

View full text Add to dashboard Cite

show abstract

“…The concept of the sliding dichotomy approach has been embraced by the clinical field and has been adopted for the primary analysis of a number of phase III trials in TBI, stroke, and intracerebral hemorrhage. 26,27 Use of the sliding dichotomy approach requires robust prognostic models to reliably provide a baseline risk estimate in individual patients, which is a prerequisite for defining the appropriate split for dichotomization in individual patients.…”

Section: Ordinal Approaches In the Primary Efficacy Analysismentioning

confidence: 99%

IMPACT Recommendations for Improving the Design and Analysis of Clinical Trials in Moderate to Severe Traumatic Brain Injury

et al. 2010

View full text Add to dashboard Cite

Summary: Clinical trials in traumatic brain injury (TBI) pose complex methodological challenges, largely related to the heterogeneity of the population. The International Mission on Prognosis and Clinical Trial Design in TBI study group has explored approaches for dealing with this heterogeneity with the aim to optimize clinical trials in TBI. Extensive prognostic analyses and simulation studies were conducted on individual patient data from eight trials and three observational studies. Here, we integrate the results of these studies into the International Mission on Prognosis and Clinical Trial Design in TBI recommendations for design and analysis of trials in TBI:• Details of the major baseline prognostic characteristics should be provided in every report on a TBI study; in trials they should be differentiated per treatment group. We also advocate the reporting of the baseline prognostic risk as determined by validated prognostic models.• Inclusion criteria should be as broad as is compatible with the current understanding of the mechanisms of action of the intervention being evaluated. This will maximize recruitment rates and enhance the generalizability of the results.• The statistical analysis should incorporate prespecified covariate adjustment to mitigate the effects of the heterogeneity.• The statistical analysis should use an ordinal approach, based on either sliding dichotomy or proportional odds methodology.Broad inclusion criteria, prespecified covariate adjustment, and an ordinal analysis will promote an efficient trial, yielding gains in statistical efficiency of more than 40%. This corresponds to being able to detect a 7% treatment effect with the same number of patients needed to demonstrate a 10% difference with an unadjusted analysis based on the dichotomized Glasgow outcome scale.

show abstract