(Stroke. 2000;31:791.)
© 2000 American Heart Association, Inc.
Letters to the Editor |
Surgery for Intracerebral Hemorrhage
STICH, Department of Neurosurgery, University of Newcastle upon Tyne, Newcastle upon Tyne, UK
To the Editor:
We were pleased to see the report of the randomized feasibility study of early surgical treatment for supratentorial intracerebral hemorrhage by Zuccarello et al.1
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 3 4 5 6 7 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.
References
1. Zuccarello M, Brott T, Derex L, Kothari R, Sauerbeck L, Tew J, Van Loveren H, Yeh H, Tomsick T, Pancioli A, Khoury J, Broderick J. Early surgical treatment for intracerebral hemorrhage: a randomized feasibility study. Stroke.. 1999;30:1833–1839.
2. McKissock W, Richardson A, Taylor J. Primary intracerebral haematoma: a controlled trial of surgical and conservative treatment in 180 unselected cases. Lancet.. 1961;2:221–226.
3. Auer LM, Diensburger W, Niederkorn K, Gell G, Kleinert R, Schneider G, Holzer P, Bone G, Mokry M, Korner E, Kleinert G, Hanusch S. Endoscopic surgery versus medical treatment for spontaneous intracerebral haematoma: a randomized study. J Neurosurg.. 1989;70:530–535.
4. Juvela S, Heiskanen O, Poranen A, Valtonen S, Kuurne T, Kaste M, Troupp H. The treatment of spontaneous intracerebral haemorrhage: a prospective randomised trial of surgical and conservative treatment. J Neurosurg.. 1989;70:755–758.
5. Batjer HH, Reisch JS, Allen BC, Plaizier LJ, Su CJ. Failure of surgery to improve outcome in hypertensive putaminal haemorrhage: a prospective randomised trial. Arch Neurol.. 1990;47:1103–1106.
6. Morgenstern LB, Frankowski RF, Shedden P, Pasteur W, Grotta JC. Surgical treatment for intracerebral hemorrhage (STICH): a single-center, randomised clinical trial. Neurology.. 1998;51:1359–1363.
7. Prasad K, Shrivastava A. Surgery for supratentorial intracerebral haemorrhage (Cochrane Review). In: The Cochrane Library, Issue 3, 1999. Oxford, UK: Update Software.
8. Fernandes HM, Mendelow AD. Spontaneous intracerebral haemorrhage: a surgical dilemma. Br J Neurosurg.. 1999;13:389–394.
Response
Department of Neurology, University of Cincinnati, Cincinnati, Ohio
Department of Neurology, Mayo Clinic, Jacksonville, Florida
Service de Neurologie, Hopitaux de Lyon, Lyon, France
Borgess Research Institute, Lansing, Michigan
Department of Neurosurgery, University of Cincinnati, Cincinnati, Ohio
Key Words: intracerebral hemorrhage • clinical
trials • medical management
We would like to strongly echo the call of Gregson and colleagues for participation in randomized treatment trials of intracerebral hemorrhage. We applaud their ongoing STICH trial and hope recruitment goals are met quickly. Multiple attempts to obtain pilot funding for a multicenter, ultra-early clinical trial in the United States have not been successful to date.
It is our belief that a randomized surgical trial of intracerebral hemorrhage should include 2 critical components: (1) ultra-early removal of blood from the brain parenchyma and (2) standardization of techniques that minimize brain injury and maximize clot removal, such as stereotactic approaches to deep-seated hemorrhages. Timely removal of the blood clot for us would preferably be within the first 3 or 4 hours after onset, hopefully within 6 to 8 hours, and at the latest within 12 hours of onset. Such an approach requires a strong commitment to improving the logistics of rapid medical and surgical treatment of patients with intracerebral hemorrhage. Solutions to these logistical problems should first be addressed in the context of a multicenter pilot study. Such a pilot study would also help standardize the medical and surgical approaches to these patients. After completion of such a pilot trial, the benefits and risks of surgical removal of intracerebral hemorrhage should be examined in a large randomized trial.
As we search for the first proven treatment for intracerebral hemorrhage, we should observe the lessons learned in randomized trials of acute ischemic stroke. The growing number of failed neuroprotective trials and the lack of clear success using thrombolytics beyond 3 hours illustrate that it is not only the therapy that is critical but also the time at which it is delivered. We strongly urge the STICH investigators to minimize the time from onset to treatment in their trial. Otherwise, they may replicate previously negative, smaller, randomized surgical trials that also used a longer time window to treatment.
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