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

Lookup NU author(s): Professor Alexander Mendelow, Dr Barbara Gregson, Dr Elise Rowan

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Abstract

Background: The balance of risk and benefit from early neurosurgical intervention for conscious patients with superficial lobar intracerebral haemorrhage (ICH) of 10 to 100ml and no intraventricular haemorrhage (IVH) admitted within 48 hours of ictus is unclear. Methods: This international multi-centre parallel-group trial compared early surgical haematoma evacuation within 12 hours of randomisation plus medical treatment with initial medical treatment alone (later evacuation was allowed if judged necessary). The primary outcome measure was a prognosis-based dichotomised outcome of the eight-point extended Glasgow Outcome Scale (GOSE) obtained by postal questionnaires mailed to patients at 6 months. Analysis was by intention to treat. Findings: 601 patients from 78 centres in 27 countries were randomised and follow-up was available for 583 (97·7%): 174/297 (59%) allocated to early surgery had an unfavourable outcome versus 178/286 (62%) patients allocated to initial conservative treatment (odds ratio 0·86 [95% CI 0·62 – 1·20], p=0·37); absolute difference 4% (-4·3 to 11·6). A secondary ordinal analysis showed a non-significant improvement in outcome with odds ratio 0·77 [95% CI 0·58 - 1·03, p = 0·075]. A statistically non-significant increase in survival was also observed in the early surgery group (p=0·074). Interpretation: Using the prognosis-based outcome, the STICH II trial did not find statistically significant evidence to support the hypothesis that early surgery compared to initial conservative treatment (with delayed surgery if the patient deteriorates) improves outcome in conscious patients in whom there is a superficial ICH between 10-100ml and no evidence of IVH. The STICH II results confirm that early surgery does not increase death or disability at 6 months and may have a small but clinically relevant survival advantage for patients with spontaneous superficial ICH without IVH.


Publication metadata

Author(s): Mendelow AD, Gregson BA, Rowan EN, Murray GD, Gholkar A, Mitchell PM, for the STICH II Investigators

Publication type: Article

Publication status: Published

Journal: Lancet

Year: 2013

Volume: 382

Issue: 9890

Pages: 397-408

Print publication date: 29/05/2013

ISSN (print): 0140-6736

ISSN (electronic): 1474-547X

Publisher: The Lancet Publishing Group

URL: http://dx.doi.org/10.1016/S0140-6736(13)60986-1

DOI: 10.1016/S0140-6736(13)60986-1


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