Clinical Trial

Accuracy of EEG Slow Wave Activity in Predicting Favourable Outcome in Patients With Hypoxic Brain Injury - A Substudy of STEPCARE Trial

Study acronym: PROPEASTEPCARE
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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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-08-19.
Trial Details
NCT Number NCT06564675
Lead Sponsor University of Helsinki
Collaborators: University of Oulu, Skane University Hospital, Helsinki University Central Hospital, Kuopio University Hospital, Tampere University, Charite University, Berlin, Germany, Oslo University Hospital, Tampere University Hospital
Conditions Out-Of-Hospital Cardiac Arrest
Enrollment 300 participants
Start Date 2023-08-01
Primary Completion 2026-08-31 (estimated)
Study Completion 2027-03-03 (estimated)
Updated on ClinicalTrials.gov 2024-08-28