Surgery for intracerebral hemorrhage.

Abstract

This study provides yet more evidence of the need for a large randomized trial of surgery for spontaneous intracerebral hemorrhage, as has been shown previously. 2–8 We wish to inform your readers of the progress of such a trial. The STICH (Surgical Trial in Intracerebral Haemorrhage) has been funded by the Medical Research Council (UK) but is open to centers from any country, and we would invite interested centers to contact us. STICH is a multicenter, pragmatic, randomized trial aiming to recruit 1000 patients. The trial is managed by a team at Newcastle University (UK). To date, we have 68 centers from the United Kingdom, Germany, Sweden, Spain, Hungary, Poland, Czech Republic, Italy, Belgium, Greece, Ukraine, Russia, South Africa, Hong Kong and the United States. Randomization is performed by telephoning the Randomisation Service at Oxford University (UK) after identifying a patient, gaining consent, and completing a randomization form. An additional form is completed 2 weeks later (or at death or discharge if earlier) to record patient status at this point and details of any surgery or adverse events. Follow-up at 6 months is obtained by the team in Newcastle, who send a questionnaire to each patient for completion. So far we have recruited 273 patients to the study, and complete 6-month follow-up data has been achieved for 130 patients. The trial is being carried out following the MRC Guidelines for Good Clinical Practice in Clinical Trials, and the data will be analyzed by treatment group after the recruitment of the final patient. Our study will permit us to investigate whether time to surgery has an effect on outcome. Time to randomization is up to 72 hours after ictus, although 30% of patients are randomized within 12 hours. Patients randomized to early surgery receive the treating surgeon’s preferred method of surgery, as soon as possible within 24 hours, and best medical care. Patients randomized to initial conservative treatment receive best medical care, including early transfer from the neurosurgery department if appropriate. Late surgery may be performed if the patient’s condition changes and surgery becomes appropriate. Patients can be included in the study only if the neurosurgeon is uncertain about the need for surgery. To achieve our target sample of 1000 as soon as possible, we would welcome participation of additional centers. Anyone who wishes to join the study should email us at stich@ncl.ac.uk.