Dear TELSTAR-2 collaborators,
Please ensure that the eCRF is filled out fully and correctly. We would like to ask your attention for the following:
- Complete the eCRF up to the ICU discharge form. Follow-up and end-of-study forms will be completed by the central study team.
- Baseline examination data should be recorded at time of randomization, after diagnosis of ESE (not ICU admission)
- For both treatment arms, complete treatment medication data (of note, this is treatment that is initiated after randomization).
- Complete the SAE form in the event of patient death.
- In case of a non-consenting representative, ask for consent to collect the primary outcome (especially if this is death) and for use of data that are collected in current care. Add a note to the patient’s medical record.
Current status
- 17 centres are actively screening patients.
- 41 patients have been included.