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

Study acronym: PROPEASTEPCARE
StatusRecruiting
PhaseNot specified
Started
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Record status
This record was last updated August 28, 2024 (before its estimated August 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Study description expanded, about 2 wordsv2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
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
(from sponsor)		 Out-Of-Hospital Cardiac Arrest
Related terms Out-of-Hospital Cardiac Arrest
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov