Surgical Trial in Intracerebral Haemorrhage (S.T.I.C.H)
The International Surgical Trial in Intracerebral haemorrhage has been set up to determine the role of surgery in spontaneous supratentorial intracerebral haemorrhage. This is an interim report as the results will remain blinded until all patients have be
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Surgical Trial in Intracerebral Haemorrhage (S.T.I.C.H) A. D. Mendelow on behalf of the investigators Department of Surgery (Neurosurgery), University of Newcastle, England, UK
Summary The International Surgical Trial in Intracerebral haemorrhage has been set up to determine the role of surgery in spontaneous supratentorial intracerebral haemorrhage. This is an interim report as the results will remain blinded until all patients have been recruited and followed up. Keywords: Intracerebral haemorrhage; stroke; surgery; craniotomy.
Introduction There is clinical uncertainty about the need for surgical evacuation of spontaneous supratentorial intracerebral haemorrhage (ICH). Previous trials have yielded conflicting results. Meta-analysis of existing trials has revealed that there is no significant benefit from surgery [1]. Two subsequent trials have also failed to reveal a conclusive result one way or the other [2, 3]. Experimental studies have shown that removal of a mass lesion designed to simulate a haematoma resulted in less ischaemic neuronal damage and a smaller volume of ischaemic tissue [4]. Clinical studies with Single Photon Emission Tomography (SPECT) in patients with ICH have confirmed some of these experimental findings in that the area of ischaemia is much larger than the haematoma itself [5]. There are some clear-cut reasons for operation: for example, a young patient with a superficial right-sided lobar haematoma who deteriorates from an initially orientated state of consciousness would need surgery in the opinion of most UK neurosurgeons [6]. There are also some patients where most neurosurgeons would agree that no operation is required either because the patient is too ill or because he or she is too well. There are patients between these limits in whom there is uncertainty about the need for surgery. This uncertainty creates the
circumstances for undertaking another formal randomised controlled trial with sufficient power to resolve the issue.
The Trial The STICH trial has set out to discover if "early surgical removal" of the clot is better than "initial conservative treatment". The trial was funded by the UK Stroke Association initially and is now funded by the Medical Research Council. The power calculations indicate that a total of 1000 patients will be required allowing for cross-overs which occur most frequently from the "initially conservative group" to later surgery. The primary outcome measure is the Glasgow Outcome Score at 6 months using a postal questionnaire. Other secondary outcome measures include the modified Rankin Score, the Barthel index, mortality, length of hospital stay and an economic analysis.
Progress to Date So far (August 1999) there have been 208 patients randomised from 65 Centres. Recruitment will continue until the target has been reached or until the Data Monitoring and Ethics committee stop the trial because one group is doing significantly better than the other. Analysis of pooled results has indicated that the randomised patients have a median age of 63 years a
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