NCT06979700 Early WAKE-up Predictors After Out-of-Hospital Cardiac Arrest
| NCT ID | NCT06979700 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Cardiac Arrest (CA) |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-05-13 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2025-05-13 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 * Known back or hip condition that precluded the patients from being positioned with backrest from 0 to 45-degree angle * Known or suspected Long QT Syndrome (LQTS) * Known active fungal disease. Localized skin lesions do not exclude patients from inclusion * Estimated body weight \<45kg
Contact & Investigator
Christian Hassager, MD, DMSc
STUDY CHAIR
Department of Cardiology, Rigshospitalet
Frequently Asked Questions
Who can join the NCT06979700 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Arrest (CA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06979700 currently recruiting?
Yes, NCT06979700 is actively recruiting participants. Contact the research team at chtorp@rm.dk for enrollment information.
Where is the NCT06979700 trial being conducted?
This trial is being conducted at Aarhus N, Denmark, Copenhagen, Denmark.
Who is sponsoring the NCT06979700 clinical trial?
NCT06979700 is sponsored by University of Aarhus. The principal investigator is Christian Hassager, MD, DMSc at Department of Cardiology, Rigshospitalet. The trial plans to enroll 250 participants.