Early WAKE-up Predictors After Out-of-Hospital Cardiac Arrest (NCT06979700) | Clinical Trial Compass
RecruitingNot Applicable
Early WAKE-up Predictors After Out-of-Hospital Cardiac Arrest
Denmark250 participantsStarted 2025-05-13
Plain-language summary
WAKE-OHCA is a prospective observational substudy of the Danish Out-of-Hospital Cardiac Arrest (DANOHCA) trial, identifier NCT05895838. The aim is to collect early neuromonitoring data to identify key predictors of successful wake-up.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years
* OHCA of presumed cardiac cause
* Sustained ROSC, defined as persistent signs of circulation and no need for chest compressions or mechanical circulatory support for 20 minutes
* Unconsciousness (GCS \<9) (patients not able to obey verbal commands) after sustained ROSC at the time of randomization
Exclusion Criteria:
* Females of childbearing potential if pregnancy is suspected (unless a negative HCG test can rule out pregnancy within the inclusion window)
* Known bleeding diathesis (medically induced coagulopathy (e.g. warfarin, NOAC, clopidogrel) does not exclude the patient)
* Suspected or confirmed acute intracranial bleeding
* Suspected or confirmed acute stroke
* Unwitnessed asystole
* Known limitations in therapy and Do Not Resuscitate-order
* Known disease making 180 days survival unlikely
* Known pre-arrest CPC 3 or 4 functional status
* \>3 hours (180 minutes) from ROSC to screening
* Systolic blood pressure \<80 mm Hg despite fluid loading/vasopressor and/or inotropic medication (If the systolic blood pressure is recovering during the inclusion window of 180 minutes the patient may be included)
* Use of intra-aortic balloon pump/axial flow device/ECMO (If the patient is weaned and the device is removed during the inclusion window of 180 minutes the patient may be included)
* Temperature on admission \<30°C
* Known allergy for dexamethasone or olanzapine
* Ongoing (within 48 h) treatment with olanzapine or dexamethasone
* Know…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is focused on predicting who will wake up after an out-of-hospital cardiac arrest using tests like EEG, pupillometry, and ultrasound — does my loved one's current neurological status make them a candidate worth discussing for this kind of monitoring study?
2Since this trial is listed as 'Phase NA,' it seems to be an observational study rather than one testing a new treatment — can you explain whether participating would change my loved one's actual care, or would it only involve extra monitoring and measurements?
3The study is measuring things like optic nerve sheath diameter and transcranial Doppler ultrasound to predict brain recovery — are these types of assessments already being done as part of standard care, and what would be added if we participated in this trial?
4The primary goal is identifying who successfully wakes up after cardiac arrest — how might the data collected in this study actually help guide decisions about my loved one's treatment or withdrawal of care discussions?
5Given that this trial is actively recruiting, what is the realistic timeline for participation, and are there any risks or burdens associated with the extra monitoring procedures like repeated ultrasounds or EEG recordings that we should weigh before agreeing to enroll?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients with successful wake-up
Timeframe: 0-6 hours or 28-36 hours according to DANOHCA randomization.