As you all know, the pilot phase is complete! During the analysis we have taken some matters into consideration and made some minor updates to the protocol. This shall be released soon. However, the inhospital eCRF has been updated accordingly and this is published today. In the protocol to be released there are two updates that affects the inhospital eCRF. One including a change that states that neurological prognostication is to be performed on all participants, (added text ➡️) unconscious with a Glasgow Coma motor Score ≤5 and still in the ICU after 72 hours after randomization. This means that should your patient be awake, there is no reason to perform a prognostication of the patients neurological outcome. The eCRF now includes a variable to confirm whether or not neurological prognostication has been performed which reflects this very thing.
The other addition is that you are now able to fill in the date of which when the patient died during hospital stay, if so took place. Previously, date of death was only reflected in the follow up eCRF and in the case where the patient died during hospital stay the follow up eCRF seldom got filled in. Therefore, this variable is now added to the inhospital eCRF as well.
Don’t forget to write a note on the previous inhospital eCRF-copy stating that it is invalid from today’s date and add the new pdf-copy to your investigator site files 🌟