1,888 participants will be randomised in a 1:1 ratio using random block sizes. The randomisation will be performed using tablet or smartphone accessing an online randomisation site. The randomisation sequence is made by a independent datamanager.
The randomisation site can be accesed using QR-codes
Screen shot of the randomisation site
The trial will be single blinded with patients blinded to treatment allocation. The EMS providers will be instructed to keep the patients blinded, but they will not themselves be blinded
To account for the risk of different in-hospital post-trial care, in-hospital staff will be blinded
for allocation. If adverse events occur, the EMT or paramedic will be able to provide
information on allocation. Additionally, the trial personnel can offer information about patient
allocation if such information becomes necessary. Thus, a protocol for emergency unblinding is
not necessary.
