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Lancet. 2013 Aug 3;382(9890):397-408. doi: 10.1016/S0140-6736(13)60986-1. Epub 2013 May 29.

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

Collaborators (239)

Sandercock P, Ford G, Barer D, Strong A, Mitchell PM, Gholkar AR, Murray GD, Mendelow AD, Gregson BA, Hanley D, Hope DT, Skene A, Fernandes HM, Metcalfe S, Iqbal A, Gholkar A, Prasad KS, Mendelow AD, Gregson BA, Rowan EN, Kenyon GM, Chilton L, Liao Z, Andras A, Francis R, Bailey L, Fanarjyan R, Kaye A, Shehab-Eldien AE, King A, Wassmann H, Stranjalis G, Sharma BS, Levi L, Valeinis E, Krivoshapkin A, Eljamel S, Vazquez-Barquero A, Barlas O, Loftus C, Minasyan A, Davis S, Kitchener N, Tyrrell P, Steiner T, Vemmos K, Prasad K, Nof SH, Millers A, Makhovskaya T, Salman RA, Laez RM, Bahar S, Eidelman B, Freeman A, Davis S, Hand P, Kleinpeter G, Findlay M, Zhao Y, Sin Y, Hu J, Krejci T, Poticny S, Benes V, Bradac O, Mohapl M, Smrcka M, Juran V, Svoboda K, Buchvald P, Benes V 3rd, Abdelaziz OS, Zidan I, Shehab-Eldien AE, Kandil EM, Taher HM, El-Faresy MF, Sepehrnia A, Kiwit J, Schreiber S, Youssef F, Buchfelder M, Swozil F, Kleindienst A, Marin M, Megele M, Hänggi D, Beseoglus K, Kiening K, Orakcioglu B, Schiebel P, Holling M, Wassmann H, Schwerdtfeger K, Szczygielski J, Nowak G, Spuck S, Sadowy K, Schroder HW, Müller C, Hamann GF, Schönmayr R, Juettler E, Woitzik J, Neugebauer H, Waschke A, Kalff R, Chehade Y, Tsitsopoulos P, Stranjalis G, Stavrinou L, Buki A, Szapary Pecs L, Dobai J, Agrawal A, Kakani A, Rao SA, Venkataramana NK, Naik AL, Grewal SS, Gupta B, Bhattacharya R, Murty TV, Indira Devi B, Jagath Lal G, Chandra PS, Tripathi M, Sharma BS, Sridhar K, Sengupta R, Nair S, Menon G, Ramana PV, Jagannath PM, Levi L, Zaaroor M, Delfini R, Pichierri A, Morita A, Kimura T, Auslands K, Valeinis E, Mikijanskis R, Gvazdaitis A, Jacikevicius K, Liutkus D, Lozance K, Chaparoski A, Pangovski I, Rahman N, Abdullah JM, Sim SK, Romero-Vargas S, Mendez-Rosito D, Ruiz-Sandoval J, Roka YB, Koirala BP, Sharma K, Mahmood K, Salahuddin T, Khan MT, Khan FF, Nowak S, Sokol B, Szydlik P, Mariak Z, Kochanowicz J, Florian IS, Kiss PA, Ples H, Angelescu MA, Hanas MS, Krivoshapkin A, Elgamal E, Choy DK, Teo KJ, Mokgokong S, Sarabia RS, Reganon IA, Galarza M, Vazquez-Barquero A, Pinto Rafael I, Garibi J, Pomposo I, Sarabia R, Ibanez J, Gonzalez E, Dominguez C, Muñoz L, Kularathne HS, Perera SD, Kamani P, Barlas O, Barlas NY, Timothy J, Mathew R, Strachan R, Metcalfe S, King A, Patel H, Bell BA, Jones TL, Bulters D, Belli A, Ross S, Eljamel S, Falcone F, Critchley G, Kirkpatrick P, Crossman J, Mendelow AD, Mitchell P, Ross N, Bhattathiri P, Metcalfe S, Holliman D, Bhatt P, Kamel M, Eldridge P, Gurusinghe N, Kumarasinghe N, Salman RA, Whittle I, Kureshi I, Hosig L, Weaver M, Sultan F, Laske D, Connolly P, Zipfel G, German J, Schneck M, Loftus C, Cockroft KM, Eidelman BH, Meschia JF, Amin-Hanjani S, Slavin K.

Author information

  • 1Newcastle University, Neurosurgical Trials Unit, Newcastle upon Tyne, UK.

Erratum in

  • Lancet. 2013 Aug 3;382(9890):396.

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.

FUNDING:

UK Medical Research Council.

Copyright © 2013 Mendelow et al. Open Access article distributed under the terms of CC BY-NC-ND. Published by Elsevier Ltd. All rights reserved.

Comment in

PMID:
23726393
[PubMed - indexed for MEDLINE]
PMCID:
PMC3906609
Free PMC Article

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