Details of HTA project in progress
Last updated: 31 August 2010 - Next update due: 7 September 2010
Research type: |
Primary Research (e.g. trial) |
Project title: |
Surgical Trial In Traumatic intraCerebral Haemorrhage [STITCH) |
Project ref: |
07/37/16 |
Cost: |
£2,328,920 |
Chief Investigator : |
Professor David Mendelow, Professor of Neurosurgery, Department of Neurosurgery, University of Newcastle upon Tyne |
Project Website |
http://research.ncl.ac.uk/trauma.STITCH/ |
Start Date: |
September 2009 |
Estimated date of publication in HTA journal series: |
Mid 2015. This date takes account of time for report preparation and printing based on current average times for these activities. |
Plain English Summary |
At present it is known that patients with a bleed on the surface of the brain following a head injury benefit from urgent surgery but it is not known whether patients with a bleed inside the brain would also benefit from surgery or not. These patients have a poor outcome with between 30% and 60% being dead, vegetative or with severe disability at six months. This study will provide evidence for whether or not surgery is of benefit to patients with a bleed or bruise inside the brain following a head injury. Patients will be identified when they are assessed in the neurosurgical department after their head injury. Those eligble according to the inclusion and exclusion criteria will be randomised to either receive early surgery to remove the blood from the brain or to receive best medical treatment and delayed surgery if they deteriorate. Both groups will receive best medical treatment throughout and outcome will be assessed at six months. The research will be undertaken by the team based in neurosurgery at Newcastle University who already have expertise in carrying out multicentre studies in a related field. The centres recruited will be those already collaborating successfully with the team in other studies plus those identified by the TARN (Trauma Audit and Research Network), EBIC (European Brain Injury Consortium) and EMN (Euroacademia Multidisciplinaria Neurotraumatologica). The study will be highly successful if a definitive answer is achieved to the question. If the study is neutral it will add to the research evidence because there is no good quality research evidence about traumatic ICH at present. The main ethical issue is that many of the subjects will not be able to consent for themselves because of their head injury. In this case consent will be sought from the closest relative who is willing and able to provide assent, as in STICH and STICH II. This team has an established infrastructure of collaborative researchers who have demonstrated their ability to complete such difficult studies having successfully carried out an international multicentre randomised controlled trial in spontaneous brain haemorrhage and presently undertaking a further trial in a subgroup of patients with spontaneous brain haemorrhage. |
Project Abstract: |
Design: A multicentre pragmatic randomised parallel group trial. Setting: Neurosurgical units (ITU, HDU and neurosurgical wards) identified from existing collaborative research networks especially those taking part in STICH II, and members of Brain IT (Neuro-intensive care monitoring research group), EMN (Euroacademia Multidisciplinaria Neurotraumatologica), EBIC (European Brain Injury Consortium), GNAMED (Scottish and Newcastle Neurosurgery research group) and TARN (Trauma Audit and Research Network) Target population: Patients with evidence of a traumatic supratentorial ICH or contusion of 25ml or more on CT scan, who are within 12 hours of head injury and for whom the responsible neurosurgeon is in equipoise about the benefits of either treatment will be eligible for the study. They will not have any evidence of a surface haematoma (EDH or SDH) or of severe multiple injury or spinal cord injury or of severe pre-existing physical or mental disability or severe co-morbidity which might interfere with assessment of outcome at six months. Their permanent residence will be in a study country. Consent will be obtained from the patient or their closest relative as appropriate and patients will be randomised using an independent 24-hour randomisation service. Randomising clinicians will complete a one-page randomisation form prior to telephoning the service. This will be backed by 24-hour availability of Trial Investigators who can advise on patient eligibility. Minimisation will be used to ensure that the two groups are balanced within country, age, Glasgow Coma Score, time from injury and volume of haematoma. Health technology being assessed: If the patient is allocated to early surgery evacuation of the haematoma will be undertaken by a method of the surgeon's choice within 12 hours of randomisation. If the patient is allocated to initial conservative treatment delayed evacuation may be undertaken if it becomes appropriate later. Both groups will be carefully monitored according to standard neurosurgical practice. Measurement of costs and outcomes: Structured six-month postal questionnaires have previously been designed for the STICH study and translated into all languages required. Having checked with the consultant that the patient is still alive and resident at the same address these will be sent to the patient for completion by the patient or relative. In countries where the postal system is poor patients will be requested to attend a follow-up clinic. Questionnaires will then be distributed and collected. In countries where literacy or language/dialect is problematic a 'blinded' interviewer will administer the questionnaire. Additional 12 month postal questionnaires will be sent to a subgroup of patiennts. A follow-up form will be completed by the neurosurgeon at the time of discharge/transfer from the neurosurgery unit or at two weeks whichever is earlier. Brain IT centres will collect continuous intracranial pressure (ICP) and cerebral perfusion pressure (CPP) monitoring data in order to investigate optimal thresholds for clinical management in relation to outcome. In a subset of countries including the UK , all relevant health care costs , including length of hospital stay and the costs associated with surgical treatment (theatre time, consumables, overheads), health care resource use outside hospital, |
ISRCTN* number: | ISRCTN 19321911 (*International Standard Randomised Controlled Trial Number) URL of this project on the Controlled Trials Website: http://www.controlled-trials.com/ISRCTN19321911 |
Project Protocol: |
Project protocol (pdf format, 394 kbytes) |
URL of this page: |
http://www.hta.ac.uk/1756 |
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