A Study Protocol published in Trials discusses TRAIN: an ongoing trial protocol that will assess the impact of two different strategies of determining when to administer a blood transfusion in critically ill patients with a primary acute brain injury.
For patients with ICH, the following data are collected: ICH volume > 30 mL on the initial CT scan ; the presence of intra-ventricular hemorrhage; location ; ICP monitoring within the first 48 h; and pupillary reactivity on arrival.
Data will be collected and stored as described at point 19, into the eCRF. After 6 months, patients who are still alive will be contacted by phone or by face-to-face meeting, according to local practice, for a structured interview to obtain the eGOS scale. The eGOS is widely used to assess neurological outcome in this setting [As crossover to another treatment arm than allocated is allowed, the crossover will be mentioned in the eCRF.
Statistical methods: analysis to handle protocol non-adherence and any statistical methods to handle missing data
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