Surgical Trial in Lobar Intracerebral Haemorrhage

Stroke is the leading cause of disability in the UK and the third most common cause of death. Brain haemorrhage accounts for 20% of all strokes and is even more common as a cause of stroke in younger patients. Despite this, neurosurgeons do not know whether to operate or not in many of their patients. A previous study (STICH I) identified a promising subgroup of patients in whom surgery might be of benefit but a further larger study is required to prove it. The Surgical Trial in Lobar Intracerebral Haemorrhage (STICH II) is a study to investigate whether a policy of early operation to remove the clot following a brain haemorrhage gives a better outcome than a policy of wait-and-see. Six hundred patients from 40 centres around the world will be included in the study.

Patients admitted to hospital with a brain haemorrhage are assessed by the neurosurgeon. Some patients are known to need an operation if there is a large clot and their condition worsens. It is known that some patients do not need an operation because the clot is small. Between these extremes there is little evidence about which is the best treatment but there have been some recent experiments that have suggested that early removal of the clot may reduce brain damage. Further analysis of a recent large study has suggested that this may particularly be the case for haemorrhages close to the surface of the brain that do not require cutting through a large amount of healthy brain to reach the haemorrhage. This group of patients are asked if they are willing to take part in the study.

If a patient agrees he or she is allocated to either an early operation or to best medical treatment with a later operation if his or her condition becomes worse. All patients receive best medical treatment whichever group they are in. A questionnaire is sent to the patient six months later to be completed by the patient or carer. The questionnaire includes questions about the patient s ability to carry out activities in their daily life.

It is expected that this study will help to identify which patients will recover better from a brain haemorrhage if they have an early operation and which patients will recover better if they do not have an operation.

Stroke is the leading cause of disability in the UK and the third commmonest cause of death. Intracerebral haemorrhage accounts for 20% of all strokes and is even more common as a cause of stroke in younger patients. Despite this, clinical uncertainty remains amongst neurosurgeons regarding whether to operate or not in many of their patients. STICH I suggested that patients with lobar haematomas only were more likely to benefit from surgical intervention but this subgroup analysis was not prespecified and can only be regarded as hypothesis generating. The Surgical Trial in Lobar Intracerebral Haemorrhage (STICH II) will be an international multicentre randomised parallel group trial to investigate whether a policy of early evacuation of the haematoma in selected patients with spontaneous supratentorial lobar intracerebral haemorrhage improves outcome compared to a policy of initial conservative treatment. Six hundred patients for whom the treating neurosurgeon is uncertain about the most beneficial treatment will be randomised using a 24 hour telephone randomisation service. Case report forms will be completed at randomisation and two-weeks later and returned to the STICH office in Newcastle. The success of the two policies in reducing the size of the haematoma will be assessed by comparison of prerandomisation and one week post randomisation CT scans. Outcome will be collected via a six-month postal questionnaire to the surviving patients or their carers to assess the level of disability using the Glasgow Outcome Scale and modified Rankin Score.