Q. Is cerebral angiography a requirement for the trial?
Q. How do we join the trial?
Q. How do I use the randomisation service?
[(axbxc)/2]
Q. Why does the randomisation form require the a,b,c, measurements to be given in mm? A. For more accurate estimation of the size of the haematoma and because it is not possible to enter a decimal point using the telephone keypad.
Q. Are there any age limits for randomisation into the trial? A. There are no strict age limits. However, it is unlikely that any patient will be below 16, as the majority of bleeds below this age are likely to be congenital vascular malformations.
Q. Will any preferred method of surgical evacuation of the ICH be acceptable? A. Yes, if stated at randomisation, but the preferred method is by craniotomy.
Q. Are brainstem and cerebellar haemorrhages eligible for inclusion? A. No. This trial is for supratentorial lobar bleeds only.
Q. Are all spontaneous supratentorial haematomas eligible despite their anatomical site? A. No, only lobar bleeds within 1 cm of the cortical surface, where there is no extension into the ventricals or the basal ganglia. Please see the example scans.
Q. Is an ICH related to anticoagulant or thrombolytic treatment eligible for the trial? A. Yes but the patients anticoagulant status should be reversed prior to randomisation.
Q. If the patient is eligible for the trial, but the treating Consultant Neurosurgeon feels surgery is mandatory, what happens? A. This patient cannot be entered into the trial. Patients are only eligible if the treating Neurosurgeon is in equipoise about the need for surgical evacuation of the haematoma.
Q. Should an External Ventricular Drain (EVD) become necessary after randomisation, can the patient still be included in the trial? A. Yes. Simply record any neurosurgical procedure on the Discharge / 2 week Follow-up Form. Insertion of EVD only, without surgical evacuation of ICH still constitutes conservative treatment, and can be carried out on patients in either arm of the trial.
Q. Will Newcastle perform all the follow-up necessary for the trial? A. Yes. However, you are free to carry out routine clinical follow-up in your usual way but this will not usually be combined with trial follow-up.
Q. What time point does "deterioration" relate to on the Major Event Form? A. Acute Deterioration should be recorded as "deterioration" on the Major Event Form (Adverse Events). All Adverse Events which result in death, are life-threatening, cause permanent or severe disability or abnormally prolongs hospitalisation should be reported to the STICH office. If deterioration is during the recovery phase this should be indicated as "not related", if appropriate, and an explanation given in the box provided.
Q. I have a patient with a spontaneous ICH but there is also evidence of a small amount of subarachnoid blood. Can they still be randomised to STICH II? A. Before you can make this decision you need to check that the subarachnoid blood is not indicating and underlying aneurysm or arteriovenous malformation (AVM) by performing an angiogram (CTA, MRA or IADSA) and seeking advice from your neuro radiologist. If there is an aneurysm or AVM then the patient should not be randomised to STICH II. If there is no obvious cause for the subarachnoid blood (apart from the spontaneous ICH) then the patient can be randomised.