Study protocol questions

DISCO-TRIAL

Study protocol questions



If the patient dies, what do we do with informed consent? If the patient dies before 24h or after?

We always need informed consent, no matter how long the patient has been included.


However:


If the patient dies without regaining consciousness, and doesn't have a relative ore next of kin to sign an I.C?

We always need informed consent. However the steering committee have decided that this kind of patient is included in the study, despite the lack of informed consent.  That is, we collect the data we need for the study.

A thorough search for relatives needs to be done before the decision is made to include the patient. Always contact P.I. at Uppsala University Hospital when these situations occurs.



LBBB and RBBB How do we do?

Many patients have ECG changes after a cardiac arrest. LBBB and RBBB is not a specific marker for ongoing ischemia and have a low positive predictive value for acute coronary occlusion. Therefore, patients with LBBB or RBBB, with no other suspicion of ongoing ischemia, can be randomized in to DISCO.


If 120 minutes passes after randomization, do we exclude the patient?

No, the 120 minutes criteria is an intended time frame. The intention is to perform the angiography before 120 minutes, however STEMI patient must be prioritized if that is necessary.

Patient is still included in the study and the angiography will be done as soon as possible with the time of procedure noted.


If a patient is incorrectly included and randomized, what do we do?

The patient will still be within the study according to intention to treat.

Accordingly the study protocol should be followed, and all data collected.



What is Out of hospital? Emergency?, Waitingroom?

It is somewhat difficult to have a strict definition, but patients having a cardiac arrest after arriving to the hospital must be deemed to have a in-hospital cardiac arrest.


Witnessed. What is not witnessed?

If you hear the person falling in the next room or your partner snoring strangely at night?

This should be deemed as witnessed cardiac arrests



If the patient dies, what do we do with informed consent? If the patient dies before 24h or after?

We always need informed consent, no matter how long the patient has been included.


Can we start an eCRF for someone without an informed consent?

No, you need an informed consent from the patient or next of kin before writing in the eCRF. (you can document in the pCRF before, if you prefer)