Update on the Surgical Trial in Lobar Intracerebral Haemorrhage (STICH II): statistical analysis plan.

Barbara A Gregson,A David Mendelow,Anil R Gholkar,Gordon D Murray,Elise N Rowan,Patrick M Mitchell

doi:10.1186/1745-6215-13-222

Abstract

BackgroundPrevious studies had suggested that the outcome for patients with spontaneous lobar intracerebral haemorrhage (ICH) and no intraventricular haemorrhage (IVH) might be improved with early evacuation of the haematoma. The Surgical Trial in Lobar Intracerebral Haemorrhage (STICH II) set out to establish whether a policy of earlier surgical evacuation of the haematoma in selected patients with spontaneous lobar ICH would improve outcome compared to a policy of initial conservative treatment. It is an international, multi-centre, prospective randomised parallel group trial of early surgery in patients with spontaneous lobar ICH. Outcome is measured at six months via a postal questionnaire.ResultsRecruitment to the study began on 27 November 2006 and closed on 15 August 2012 by which time 601 patients had been recruited. The protocol was published in Trials (http://www.trialsjournal.com/content/12/1/124/). This update presents the analysis plan for the study without reference to the unblinded data. The trial data will not be unblinded until after follow-up is completed in early 2013. The main trial results will be presented in spring 2013 with the aim to publish in a peer-reviewed journal at the same time.ConclusionThe data from the trial will provide evidence on the benefits and risks of early surgery in patients with lobar ICH.Trial registrationISRCTN: ISRCTN22153967

Highlights

The Surgical Trial in Lobar Intracerebral Haemorrhage (STICH II) aims to establish whether a policy of earlier surgical evacuation of the haematoma in selected patients with spontaneous lobar intracerebral haemorrhage (ICH) will improve outcome compared to a policy of initial conservative treatment
The analysis of patients with only lobar haematomas and no intraventricular haemorrhage (IVH) using unfavourable outcome defined as dead, severely disabled or independent inside the home shows a tendency to favour surgery (Figure 1). This analysis is dominated by the Surgical Trial in Intracerebral Haemorrhage (STICH) [3], which was the motivation for undertaking STICH II
Further detailed analysis of data from the STICH study In order to plan data analysis of STICH II, it is useful to examine the data collected in the first STICH study [3] for cases that would have been eligible for STICH II under the present inclusion criteria

Summary

Introduction

The Surgical Trial in Lobar Intracerebral Haemorrhage (STICH II) aims to establish whether a policy of earlier surgical evacuation of the haematoma in selected patients with spontaneous lobar intracerebral haemorrhage (ICH) will improve outcome compared to a policy of initial conservative treatment. All patients who are randomised and have outcome measured will be included in the analysis.

Results

Conclusion