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 ...  more