Early surgery versus initial conservative treatment in patients with spontaneous supratentorial lobar intracerebral haematomas (STICH II): A randomised trial

STICH II Investigators

Research output: Contribution to journalArticle

468 Citations (Scopus)

Abstract

Background The balance of risk and benefit from early neurosurgical intervention for conscious patients with superficial lobar intracerebral haemorrhage of 10-100 mL and no intraventricular haemorrhage admitted within 48 h of ictus is unclear. We therefore tested the hypothesis that early surgery compared with initial conservative treatment could improve outcome in these patients. Methods In this international, parallel-group trial undertaken in 78 centres in 27 countries, we compared early surgical haematoma evacuation within 12 h of randomisation plus medical treatment with initial medical treatment alone (later evacuation was allowed if judged necessary). An automatic telephone and internet-based randomisation service was used to assign patients to surgery and initial conservative treatment in a 1:1 ratio. The trial was not masked. The primary outcome was a prognosis-based dichotomised (favourable or unfavourable) outcome of the 8 point Extended Glasgow Outcome Scale (GOSE) obtained by questionnaires posted to patients at 6 months. Analysis was by intention to treat. This trial is registered, number ISRCTN22153967. Findings 307 of 601 patients were randomly assigned to early surgery and 294 to initial conservative treatment; 298 and 291 were followed up at 6 months, respectively; and 297 and 286 were included in the analysis, respectively. 174 (59%) of 297 patients in the early surgery group had an unfavourable outcome versus 178 (62%) of 286 patients in the initial conservative treatment group (absolute difference 3·7% [95% CI -4·3 to 11·6], odds ratio 0·86 [0·62 to 1·20]; p=0·367). Interpretation The STICH II results confirm that early surgery does not increase the rate of death or disability at 6 months and might have a small but clinically relevant survival advantage for patients with spontaneous superficial intracerebral haemorrhage without intraventricular haemorrhage.

Original languageEnglish
Pages (from-to)397-408
Number of pages12
JournalThe Lancet
Volume382
Issue number9890
DOIs
Publication statusPublished - 01-01-2013

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Hematoma
Cerebral Hemorrhage
Random Allocation
Hemorrhage
Glasgow Outcome Scale
Intention to Treat Analysis
Conservative Treatment
Telephone
Internet
Odds Ratio
Survival
Mortality
Therapeutics

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

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title = "Early surgery versus initial conservative treatment in patients with spontaneous supratentorial lobar intracerebral haematomas (STICH II): A randomised trial",
abstract = "Background The balance of risk and benefit from early neurosurgical intervention for conscious patients with superficial lobar intracerebral haemorrhage of 10-100 mL and no intraventricular haemorrhage admitted within 48 h of ictus is unclear. We therefore tested the hypothesis that early surgery compared with initial conservative treatment could improve outcome in these patients. Methods In this international, parallel-group trial undertaken in 78 centres in 27 countries, we compared early surgical haematoma evacuation within 12 h of randomisation plus medical treatment with initial medical treatment alone (later evacuation was allowed if judged necessary). An automatic telephone and internet-based randomisation service was used to assign patients to surgery and initial conservative treatment in a 1:1 ratio. The trial was not masked. The primary outcome was a prognosis-based dichotomised (favourable or unfavourable) outcome of the 8 point Extended Glasgow Outcome Scale (GOSE) obtained by questionnaires posted to patients at 6 months. Analysis was by intention to treat. This trial is registered, number ISRCTN22153967. Findings 307 of 601 patients were randomly assigned to early surgery and 294 to initial conservative treatment; 298 and 291 were followed up at 6 months, respectively; and 297 and 286 were included in the analysis, respectively. 174 (59{\%}) of 297 patients in the early surgery group had an unfavourable outcome versus 178 (62{\%}) of 286 patients in the initial conservative treatment group (absolute difference 3·7{\%} [95{\%} CI -4·3 to 11·6], odds ratio 0·86 [0·62 to 1·20]; p=0·367). Interpretation The STICH II results confirm that early surgery does not increase the rate of death or disability at 6 months and might have a small but clinically relevant survival advantage for patients with spontaneous superficial intracerebral haemorrhage without intraventricular haemorrhage.",
author = "{STICH II Investigators} and Mendelow, {A. David} and Gregson, {Barbara A.} and Rowan, {Elise N.} and Murray, {Gordon D.} and Anil Gholkar and Mitchell, {Patrick M.} and Mendelow, {A. D.} and Gregson, {B. A.} and Rowan, {E. N.} and Murray, {G. D.} and A. Gholkar and P. Mitchell and P. Sandercock and G. Ford and D. Barer and A. Strong and Mitchell, {P. M.} and Gholkar, {A. R.} and Murray, {G. D.} and Mendelow, {A. D.} and Gregson, {B. A.} and D. Hanley and Hope, {D. T.} and A. Skene and Fernandes, {H. M.} and S. Metcalfe and A. Iqbal and A. Gholkar and Prasad, {K. S.M.} and Mendelow, {A. D.} and Gregson, {B. A.} and Rowan, {E. N.} and Kenyon, {G. M.} and L. Chilton and Z. Liao and A. Andras and R. Francis and L. Bailey and Ruben Fanarjyan and Andrew Kaye and Shehab-Eldien, {Abd Elhafiz} and Andrew King and Hansdetlef Wassmann and George Stranjalis and Sharma, {Bhawani S.} and Leon Levi and Egils Valeinis and Rao, {S. A.V.} and S. Nair and G. Menon",
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doi = "10.1016/S0140-6736(13)60986-1",
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Early surgery versus initial conservative treatment in patients with spontaneous supratentorial lobar intracerebral haematomas (STICH II) : A randomised trial. / STICH II Investigators.

In: The Lancet, Vol. 382, No. 9890, 01.01.2013, p. 397-408.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Early surgery versus initial conservative treatment in patients with spontaneous supratentorial lobar intracerebral haematomas (STICH II)

T2 - A randomised trial

AU - STICH II Investigators

AU - Mendelow, A. David

AU - Gregson, Barbara A.

AU - Rowan, Elise N.

AU - Murray, Gordon D.

AU - Gholkar, Anil

AU - Mitchell, Patrick M.

AU - Mendelow, A. D.

AU - Gregson, B. A.

AU - Rowan, E. N.

AU - Murray, G. D.

AU - Gholkar, A.

AU - Mitchell, P.

AU - Sandercock, P.

AU - Ford, G.

AU - Barer, D.

AU - Strong, A.

AU - Mitchell, P. M.

AU - Gholkar, A. R.

AU - Murray, G. D.

AU - Mendelow, A. D.

AU - Gregson, B. A.

AU - Hanley, D.

AU - Hope, D. T.

AU - Skene, A.

AU - Fernandes, H. M.

AU - Metcalfe, S.

AU - Iqbal, A.

AU - Gholkar, A.

AU - Prasad, K. S.M.

AU - Mendelow, A. D.

AU - Gregson, B. A.

AU - Rowan, E. N.

AU - Kenyon, G. M.

AU - Chilton, L.

AU - Liao, Z.

AU - Andras, A.

AU - Francis, R.

AU - Bailey, L.

AU - Fanarjyan, Ruben

AU - Kaye, Andrew

AU - Shehab-Eldien, Abd Elhafiz

AU - King, Andrew

AU - Wassmann, Hansdetlef

AU - Stranjalis, George

AU - Sharma, Bhawani S.

AU - Levi, Leon

AU - Valeinis, Egils

AU - Rao, S. A.V.

AU - Nair, S.

AU - Menon, G.

PY - 2013/1/1

Y1 - 2013/1/1

N2 - Background The balance of risk and benefit from early neurosurgical intervention for conscious patients with superficial lobar intracerebral haemorrhage of 10-100 mL and no intraventricular haemorrhage admitted within 48 h of ictus is unclear. We therefore tested the hypothesis that early surgery compared with initial conservative treatment could improve outcome in these patients. Methods In this international, parallel-group trial undertaken in 78 centres in 27 countries, we compared early surgical haematoma evacuation within 12 h of randomisation plus medical treatment with initial medical treatment alone (later evacuation was allowed if judged necessary). An automatic telephone and internet-based randomisation service was used to assign patients to surgery and initial conservative treatment in a 1:1 ratio. The trial was not masked. The primary outcome was a prognosis-based dichotomised (favourable or unfavourable) outcome of the 8 point Extended Glasgow Outcome Scale (GOSE) obtained by questionnaires posted to patients at 6 months. Analysis was by intention to treat. This trial is registered, number ISRCTN22153967. Findings 307 of 601 patients were randomly assigned to early surgery and 294 to initial conservative treatment; 298 and 291 were followed up at 6 months, respectively; and 297 and 286 were included in the analysis, respectively. 174 (59%) of 297 patients in the early surgery group had an unfavourable outcome versus 178 (62%) of 286 patients in the initial conservative treatment group (absolute difference 3·7% [95% CI -4·3 to 11·6], odds ratio 0·86 [0·62 to 1·20]; p=0·367). Interpretation The STICH II results confirm that early surgery does not increase the rate of death or disability at 6 months and might have a small but clinically relevant survival advantage for patients with spontaneous superficial intracerebral haemorrhage without intraventricular haemorrhage.

AB - Background The balance of risk and benefit from early neurosurgical intervention for conscious patients with superficial lobar intracerebral haemorrhage of 10-100 mL and no intraventricular haemorrhage admitted within 48 h of ictus is unclear. We therefore tested the hypothesis that early surgery compared with initial conservative treatment could improve outcome in these patients. Methods In this international, parallel-group trial undertaken in 78 centres in 27 countries, we compared early surgical haematoma evacuation within 12 h of randomisation plus medical treatment with initial medical treatment alone (later evacuation was allowed if judged necessary). An automatic telephone and internet-based randomisation service was used to assign patients to surgery and initial conservative treatment in a 1:1 ratio. The trial was not masked. The primary outcome was a prognosis-based dichotomised (favourable or unfavourable) outcome of the 8 point Extended Glasgow Outcome Scale (GOSE) obtained by questionnaires posted to patients at 6 months. Analysis was by intention to treat. This trial is registered, number ISRCTN22153967. Findings 307 of 601 patients were randomly assigned to early surgery and 294 to initial conservative treatment; 298 and 291 were followed up at 6 months, respectively; and 297 and 286 were included in the analysis, respectively. 174 (59%) of 297 patients in the early surgery group had an unfavourable outcome versus 178 (62%) of 286 patients in the initial conservative treatment group (absolute difference 3·7% [95% CI -4·3 to 11·6], odds ratio 0·86 [0·62 to 1·20]; p=0·367). Interpretation The STICH II results confirm that early surgery does not increase the rate of death or disability at 6 months and might have a small but clinically relevant survival advantage for patients with spontaneous superficial intracerebral haemorrhage without intraventricular haemorrhage.

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U2 - 10.1016/S0140-6736(13)60986-1

DO - 10.1016/S0140-6736(13)60986-1

M3 - Article

AN - SCOPUS:84881164520

VL - 382

SP - 397

EP - 408

JO - The Lancet

JF - The Lancet

SN - 0140-6736

IS - 9890

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