Extrait

Background and study aims STICH II is a study for patients with a type of stroke which causes bleeding into the brain (spontaneous intracerebral haemorrhage) where the bleed is close to the surface of the brain and between 10-100 ml in size. STICH II will examine whether it is better to give these patients an early operation (early surgery) or to monitor them carefully (initial conservative treatment) with an option to operate later on if necessary. Who can participate? This study is for adult patients who have had a CT scan confirming that they have a bleed in their brain. The study is for patients who in the opinion of the neurosurgeon could benefit equally from early surgery or initial conservative treatment. What does the study involve? Patients will be randomly put into either the 'early surgery' group or the 'initial conservative' group, decided by a computer system. Those who are in the 'early surgery' group will have an operation to remove the bleed in the brain within 12 hours. Those in the 'initial conservative treatment' group will be monitored closely and if necessary, receive an operation later on. Patients will have another CT scan done 5 days later. The doctor will complete a form at 2 weeks/discharge. The patient will be sent a postal questionnaire at 6 months to fill in and return. What are the possible benefits and risks of participating? The usual possible risks associated with having an operation or being managed 'conservatively' apply to this study. We cannot promise that the study will help the patients taking part, but the information we get might improve treatment of future patients with brain haemorrhage. Where is the study run from? This international study is co-ordinated by Newcastle University, Newcastle upon Tyne, UK. This study has 126 hospitals around the world taking part, from 39 countries. When is the study starting and how long is it expected to run for? The STICH II trial opened for recruitment in January 2007; it will finish when 600 patients have been recruited and their 6-month follow-up is complete. Publication of the results is planned in 2013. Who is funding the study? The trial was funded by the Medical Research Council (MRC) and funding has now been transferred to the NIHR EME programme (UK). Who is the main contact? The main contact is the team at the co-ordinating centre here in Newcastle. Their contact details can be found on our website at: http://research.ncl.ac.uk/stich / or you can email the team at [email protected]

Critère d'inclusion

• Spontaneous intracerebral haemorrhage confined to the lobar region

Liens

• ictrp
• isrctn