Dear TELSTAR-2 collaborators,
Please ensure that the trial is discussed with a patient’s legal representatives after randomization.
If the family declines participation, explicitly ask whether the use of already collected data is still permitted. In many cases, refusal applies only to further research procedures or additional contact, while use of data already collected remains acceptable.
Make sure this is clearly documented in the patient’s record. This is particularly important in the event of the patient’s death, to prevent loss to follow-up.
According to our protocol:
- If a family refuses after a patient has died, we keep a patient included: “If a patient has died before deferred consent has been obtained, his/her representative will be informed about the study treatment the patient may have received, trial procedures, and use of the collected data. No consent from the representatives will be required for use of these data.”
- If a family refuses before a patient has died, the patient will not be included. However, we will ask permission for the use of data that have already been collected, and in the case of imminent death, also of the outcome “death.”
Having said that, we are nicely on track and we are happy to have you on our mission. Let’s reach new heights together and keep our eyes and ears open for inclusions.
Current status
- 17 centres are actively screening patients.
- 37 patients have been included.