NCT06564675 Accuracy of EEG Slow Wave Activity in Predicting Favourable Outcome in Patients With Hypoxic Brain Injury - A Substudy of STEPCARE Trial
| NCT ID | NCT06564675 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Helsinki |
| Condition | Out-Of-Hospital Cardiac Arrest |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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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 300 participants in total. It began in 2023-08-01 with a primary completion date of 2026-08-31.
⚠ 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
This is an observational substudy embedded in the STEPCARE Trial. The study involves EEG analysis, covered by the ethics approval of STEPCARE Trial. The investigators aim to compare the accuracy of a continuously measured algorithm-based EEG index, C-Trend Index, with retrospective visual analysis of continuous EEG in predicting favorable functional outcome in adult patients treated in intensive care units after out-of-hospital cardiac arrest. The primary hypothesis is that the accuracy of C-Trend Index has at least 10% better accuracy in predicting favorable outcome than the visual analysis of cEEG, when assessed early, 9-12 hours after return of spontaneous circulation (ROSC).
Eligibility Criteria
Inclusion Criteria: * Age 18 years or older * OHCA, with sustained ROSC * Unconscious after ROSC * No limitations to full life support * Randomized to STEPCARE Trial in a participating center with Brainstatus device available Exclusion Criteria: * age \<18 * Previously randomized to STEPCARE * Trauma or hemorrhage as the reasons for arrest * Suspected or confirmed intracerebral hemorrhage * Allergy to adhesive material * Damaged skin at the frontal-temporal are preventing electrode attachment
Contact & Investigator
Jukka Kortelainen, MD, PhD
STUDY DIRECTOR
University of Oulu
Frequently Asked Questions
Who can join the NCT06564675 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 110 Years, studying Out-Of-Hospital Cardiac Arrest. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06564675 currently recruiting?
Yes, NCT06564675 is actively recruiting participants. Contact the research team at johanna.hastbacka@tuni.fi for enrollment information.
Where is the NCT06564675 trial being conducted?
This trial is being conducted at Helsinki, Finland, Kuopio, Finland, Tampere, Finland, Lund, Sweden.
Who is sponsoring the NCT06564675 clinical trial?
NCT06564675 is sponsored by University of Helsinki. The principal investigator is Jukka Kortelainen, MD, PhD at University of Oulu. The trial plans to enroll 300 participants.