Early Neurological Prognostication of Outcome After Out-of-hospital Cardiac Arrest A STEPCARE Prospective Substudy

What this Trial Is About

Researchers are investigating whether the neurological outcome after an out-of-hospital cardiac arrest can be predicted earlier than the currently recommended 72-hour time point. This study focuses on adult patients who suffered a cardiac arrest of presumed cardiac or unknown cause and are unconscious after resuscitation. It explores combining clinical exams, brain injury markers like neurofilament light (NFL), EEG, and head CT scans to predict poor functional outcomes at 24 hours post-arrest without false positives. The study is a prospective observational substudy within the larger STEPCARE trial, conducted by Lund University and involving multiple international centers. The study involves collecting blood samples to measure brain injury markers at 12, 24, 48, and 72 hours after randomization. EEG and CT scans are performed as early as possible after 24 hours in patients still unconscious. Additional neuroimaging and electrophysiological data, including SSEP and MRI, are collected for central blind review. Patients receive intensive care according to STEPCARE trial protocols, which include varying sedation, fever treatment, and blood pressure targets, but decisions about life-sustaining therapy withdrawal follow current guidelines and are not made solely on early exam results. Participants will be assessed with clinical exams, blood tests, EEG, and imaging during their hospital stay, with data stored securely using study IDs. Functional outcomes are evaluated six months after randomization using the modified Rankin Scale, with poor outcomes defined as moderate to severe disability or death. The study aims to determine whether early prognostic tools can predict neurological outcomes accurately and safely, with final biomarker analyses performed after trial completion.

Early Neuroprognostication After OHCA