Early Prediction of Neurological Outcome After Cardiac Arrest‐Rationale and Design of the Prospective International Observational <scp>EARLY</scp> ‐ <scp>NEURO</scp> , a <scp>STEPCARE</scp> Substudy

BACKGROUND: Guidelines discourage prediction of neurological outcome in comatose patients within the first 72 h after cardiac arrest. Increasing evidence suggests that patients with the most severe brain injury and those with no or minimal brain injury may be identified before 72 h using novel methods. We present a protocol for the EARLY-NEURO study, which aims to evaluate whether good and poor outcomes can be reliably predicted already from 24 h after cardiac arrest using the most commonly available methods. METHODS: Protocol for a prospective international multicenter substudy within the Sedation, TEmperature and Pressure after Cardiac Arrest and REsuscitation (STEPCARE) trial where adults post-arrest are randomized to minimal or deep sedation, fever treatment with or without a temperature management device and to two different targets of mean arterial blood pressure. Patients sedated or still unconscious at 24 h are examined with head computed tomography (CT) and electroencephalogram (EEG). Blood samples are collected at 24 h after randomization, and stored for analysis of the brain injury marker neurofilament light. CT and EEG examinations will be centrally evaluated for signs of a likely poor or good outcome applying standardized criteria by raters blinded to treatment allocations and patient outcomes. Intensive care treatment, neurological prognostication, and criteria for withdrawal of care will be according to the STEPCARE protocol. Timepoint and reasons for withdrawal of life-sustaining therapy (WLST) will be recorded. WLST prior to 72 h after randomization based on a presumed futile neurological prognosis is strongly discouraged. Primary outcome will be good or poor functional outcome, assessed by the modified Rankin Scale (dichotomized as 0-3 versus 4-6) at 6 months. Results will be reported in accordance with the Standards for Reporting Diagnostic Accuracy (STARD). CONCLUSIONS: Earlier prognostication aims to balance the avoidance of premature treatment withdrawal in patients with favorable potential against the prevention of unnecessary intervention in patients with a definitely poor prognosis.

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Journal
Acta Anaesthesiologica Scandinavica
Published
2026-04-17
DOI
https://doi.org/10.1111/aas.70239
Citations
1
Primary Topic
Cardiac Arrest and Resuscitation
Type
article
Field-Weighted Citation Impact
27.39

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article

Early Prediction of Neurological Outcome After Cardiac Arrest‐Rationale and Design of the Prospective International Observational EARLY ‐ NEURO , a STEPCARE Substudy

Ameldina Ceric, Maria‐Ioanna Stefanou, Janus Jacobsen, Tobias Cronberg et al.
1 citations
Acta Anaesthesiologica Scandinavica
Cardiac Arrest and Resuscitation
27.39
article

Early Prediction of Neurological Outcome After Cardiac Arrest‐Rationale and Design of the Prospective International Observational EARLY ‐ NEURO , a STEPCARE Substudy

Ameldina Ceric, Maria‐Ioanna Stefanou, Janus Jacobsen, Tobias Cronberg, Matthias Hænggi, Jessica Kåhlin, Caroline Barkholt Kamp, D. Nowak, Jens Nee, Jesper Johnsson, Georg Royl, Katie Sweet, Marjaana Tiainen, T Graf, Erik Westhall, Matt Thomas, Luis Romundstad, Gisela Lilja, Alice Lagebrant, Frances Bass, Simon Schmidbauer, Helena Levin, Joachim Düring, Margareta Lang, Christoph Leithner, Annerose Mengel, Joonas Tirkkonen, Martin Kenda, Naomi E. Hammond, Anna Lybeck, Johan Undén, Jonathan Grip, Matti Reinikainen, Christina Dam Bjerregaard Sillassen, Marion Moseby-Knappe, Paul Young, Pedro D. Wendel–Garcia, M B Skrifvars, Matthias P. Hilty, Philipp Seidel, Jonna Heinonen, Rakesh H. Jadav, Manoj Saxena, Stepani Bendel, Marjolein Admiraal, Niklas Nielsen, Matt Wise, Pascal Stammet, Johanna Hästbacka
article en
1 citations

Abstract

BACKGROUND: Guidelines discourage prediction of neurological outcome in comatose patients within the first 72 h after cardiac arrest. Increasing evidence suggests that patients with the most severe brain injury and those with no or minimal brain injury may be identified before 72 h using novel methods. We present a protocol for the EARLY-NEURO study, which aims to evaluate whether good and poor outcomes can be reliably predicted already from 24 h after cardiac arrest using the most commonly available methods. METHODS: Protocol for a prospective international multicenter substudy within the Sedation, TEmperature and Pressure after Cardiac Arrest and REsuscitation (STEPCARE) trial where adults post-arrest are randomized to minimal or deep sedation, fever treatment with or without a temperature management device and to two different targets of mean arterial blood pressure. Patients sedated or still unconscious at 24 h are examined with head computed tomography (CT) and electroencephalogram (EEG). Blood samples are collected at 24 h after randomization, and stored for analysis of the brain injury marker neurofilament light. CT and EEG examinations will be centrally evaluated for signs of a likely poor or good outcome applying standardized criteria by raters blinded to treatment allocations and patient outcomes. Intensive care treatment, neurological prognostication, and criteria for withdrawal of care will be according to the STEPCARE protocol. Timepoint and reasons for withdrawal of life-sustaining therapy (WLST) will be recorded. WLST prior to 72 h after randomization based on a presumed futile neurological prognosis is strongly discouraged. Primary outcome will be good or poor functional outcome, assessed by the modified Rankin Scale (dichotomized as 0-3 versus 4-6) at 6 months. Results will be reported in accordance with the Standards for Reporting Diagnostic Accuracy (STARD). CONCLUSIONS: Earlier prognostication aims to balance the avoidance of premature treatment withdrawal in patients with favorable potential against the prevention of unnecessary intervention in patients with a definitely poor prognosis.

Acta Anaesthesiologica ScandinavicaVol. 70(5)
Oslo University Hospital (NO), Karolinska University Hospital (SE), University of Helsinki (FI), Centre Hospitalier de Luxembourg (LU), The University of Melbourne (AU), University of Eastern Finland (FI), University of Southern Denmark (DK), University of Luxembourg (LU), Lund University (SE), National and Kapodistrian University of Athens (GR), University of Zurich (CH), Royal North Shore Hospital (AU), Stavanger University Hospital (NO), Helsinki University Hospital (FI), University Hospitals Bristol NHS Foundation Trust (GB), University Hospital of Wales (GB), Wellington Hospital (NZ), Copenhagen University Hospital (DK), Karolinska Institutet (SE), LMU Klinikum (DE), Humboldt-Universität zu Berlin (DE), Australian and New Zealand Intensive Care Society (AU), Kuopio University Hospital (FI), University Hospital of Zurich (CH), Lovisenberg Diakonale Høgskole (NO), The George Institute for Global Health (AU), University Hospital Schleswig-Holstein (DE), Tampere University Hospital (FI), German Centre for Cardiovascular Research (DE), Helsingborgs lasarett (SE), Tampere University (FI), Medical Research Institute of New Zealand (NZ), Skåne University Hospital (SE), Hertie Institute for Clinical Brain Research (DE), Innovation Skåne (Sweden) (SE), Hallands sjukhus Halmstad (SE), Monash University (AU), Medical University of Vienna (AT), Charité - Universitätsmedizin Berlin (DE), University of Tübingen (DE), Ludwig-Maximilians-Universität München (DE), University of Stavanger (NO), University of Lübeck (DE)
Itä-Suomen Yliopisto, Helsingin Yliopisto, Université du Luxembourg, Medicinska Understödsföreningen Liv och Hälsa, Deutsches Zentrum für Herz-Kreislaufforschung, Universitetet i Stavanger, University of New South Wales, Monash University, Academy of Finland, Eberhard Karls Universität Tübingen, Gentofte Hospital, Universität Wien, Lunds Universitet, Hjärt-Lungfonden, Karolinska Institutet, Kuopion Yliopistollinen Sairaala, Vetenskapsrådet, Rigshospitalet, National and Kapodistrian University of Athens, Ludwig-Maximilians-Universität München, Medizinische Universität Wien, Humboldt-Universität zu Berlin, Sigrid Juséliuksen Säätiö, Syddansk Universitet, Universität Zürich, Universitätsspital Zürich, Tays, Lovisenberg Diakonale Høgskole, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Skånes universitetssjukhus, George Institute for Global Health, Health Research Council of New Zealand, Faculty of Medicine and Health, University of Sydney
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Cardiac Arrest and Resuscitation
27.39
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