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.
Related Questions
- Should an External Ventricular Drain (EVD) become necessary after randomisation, can the patient still be included in the trial?
- What is the role of the licensed practical nurse in caring for a patient with an external cerebral ventricular catheter?
- If a patient needs a CT in preparation for radiation therapy, is precertification necessary?
