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Biomarkers of brain injury after cardiac arrest; a statistical analysis plan from the TTM2 trial biobank investigators
M. Moseby-Knappe, H. Levin, K. Blennow, S. Ullén, H. Zetterberg, G. Lilja, J. Dankiewicz, JC. Jakobsen, A. Lagebrant, H. Friberg, A. Nichol, K. Ainschough, GM. Eastwood, MP. Wise, M. Thomas, T. Keeble, A. Cariou, C. Leithner, C. Rylander, J....
Language English Country Netherlands
Document type Journal Article
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- Publication type
- Journal Article MeSH
Background: Several biochemical markers in blood correlate with the magnitude of brain injury and may be used to predict neurological outcome after cardiac arrest. We present a protocol for the evaluation of prognostic accuracy of brain injury markers after cardiac arrest. The aim is to define the best predictive marker and to establish clinically useful cut-off levels for routine implementation. Methods: Prospective international multicenter trial within the Targeted Hypothermia versus Targeted Normothermia after Out-of-Hospital Cardiac Arrest (TTM2) trial in collaboration with Roche Diagnostics International AG. Samples were collected 0, 24, 48, and 72 hours after randomisation (serum) and 0 and 48 hours after randomisation (plasma), and pre-analytically processed at each site before storage in a central biobank. Routine markers neuron-specific enolase (NSE) and S100B, and neurofilament light, total-tau and glial fibrillary acidic protein will be batch analysed using novel Elecsys® electrochemiluminescence immunoassays on a Cobas e601 instrument. Results: Statistical analysis will be reported according to the Standards for Reporting Diagnostic accuracy studies (STARD) and will include comparisons for prediction of good versus poor functional outcome at six months post-arrest, by modified Rankin Scale (0-3 vs. 4-6), using logistic regression models and receiver operating characteristics curves, evaluation of mortality at six months according to biomarker levels and establishment of cut-off values for prediction of poor neurological outcome at 95-100% specificities. Conclusions: This prospective trial may establish a standard methodology and clinically appropriate cut-off levels for the optimal biomarker of brain injury which predicts poor neurological outcome after cardiac arrest.
Adult Critical Care University Hospital of Wales Cardiff United Kingdom
Anaesthesiology and Intensive Care Department of Surgical Sciences Uppsala University Uppsala Sweden
Biostatistical Department Roche Diagnostics International AG Rotkreuz Switzerland
Clinical Development Department Roche Diagnostics International AG Rotkreuz Switzerland
Clinical Neurochemistry Laboratory Sahlgrenska University Hospital Mölndal Sweden
Clinical Studies Sweden Forum South Skåne University Hospital Lund Sweden
Department of Anaesthesiology and Intensive Care Medicine Aarhus University Hospital Aarhus Denmark
Department of Clinical Medicine Aarhus University Aarhus Denmark
Department of Clinical Sciences Lund Neurology Lund University Skåne University Hospital Lund Sweden
Department of Intensive Care Austin Hospital Melbourne VIC Australia
Essex Cardiothoracic Centre MSE Basildon Essex United Kingdom
Hong Kong Center for Neurodegenerative Diseases Clear Water Bay Hong Kong China
Intensive Care Unit Alfred Hospital Melbourne Australia
Intensive Care Unit University Hospitals Bristol and Weston England United Kingdom
Medical Intensive Care Unit AP HP Cochin Hospital Paris France Paris Cité University Paris France
MTRC Anglia Ruskin School of Medicine Chelmsford Essex United Kingdom
The Australian and New Zealand Intensive Care Research Centre Monash University Melbourne Australia
The Copenhagen Trial Unit Centre for Clinical Intervention Research Denmark
UK Dementia Research Institute at UCL London United Kingdom
University College Dublin Clinical Research Centre St Vincent's University Hospital Dublin Ireland
References provided by Crossref.org
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- $a Background: Several biochemical markers in blood correlate with the magnitude of brain injury and may be used to predict neurological outcome after cardiac arrest. We present a protocol for the evaluation of prognostic accuracy of brain injury markers after cardiac arrest. The aim is to define the best predictive marker and to establish clinically useful cut-off levels for routine implementation. Methods: Prospective international multicenter trial within the Targeted Hypothermia versus Targeted Normothermia after Out-of-Hospital Cardiac Arrest (TTM2) trial in collaboration with Roche Diagnostics International AG. Samples were collected 0, 24, 48, and 72 hours after randomisation (serum) and 0 and 48 hours after randomisation (plasma), and pre-analytically processed at each site before storage in a central biobank. Routine markers neuron-specific enolase (NSE) and S100B, and neurofilament light, total-tau and glial fibrillary acidic protein will be batch analysed using novel Elecsys® electrochemiluminescence immunoassays on a Cobas e601 instrument. Results: Statistical analysis will be reported according to the Standards for Reporting Diagnostic accuracy studies (STARD) and will include comparisons for prediction of good versus poor functional outcome at six months post-arrest, by modified Rankin Scale (0-3 vs. 4-6), using logistic regression models and receiver operating characteristics curves, evaluation of mortality at six months according to biomarker levels and establishment of cut-off values for prediction of poor neurological outcome at 95-100% specificities. Conclusions: This prospective trial may establish a standard methodology and clinically appropriate cut-off levels for the optimal biomarker of brain injury which predicts poor neurological outcome after cardiac arrest.
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