AIMS: The TTM2-trial is a multi-centre randomised clinical trial where targeted temperature management (TTM) at 33 °C will be compared with normothermia and early treatment of fever (≥37.8 °C) after Out-of-Hospital Cardiac Arrest (OHCA). This paper presents the design and rationale of the TTM2-trial follow-up, where information on secondary and exploratory outcomes will be collected. We also present the explorative outcome analyses which will focus on neurocognitive function and societal participation in OHCA-survivors. METHODS: Blinded outcome-assessors will perform follow-up at 30-days after the OHCA with a telephone interview, including the modified Rankin Scale (mRS) and the Glasgow Outcome Scale Extended (GOSE). Face-to-face meetings will be performed at 6 and 24-months, and include reports on outcome from several sources of information: clinician-reported: mRS, GOSE; patient-reported: EuroQol-5 Dimensions-5 Level responses version (EQ-5D-5L), Life satisfaction, Two Simple Questions; observer-reported: Informant Questionnaire on Cognitive Decline in the Elderly-Cardiac Arrest version (IQCODE-CA) and neurocognitive performance measures: Montreal Cognitive Assessment, (MoCA), Symbol Digit Modalities Test (SDMT). Exploratory analyses will be performed with an emphasis on brain injury in the survivors, where the two intervention groups will be compared for potential differences in neuro-cognitive function (MoCA, SDMT) and societal participation (GOSE). Strategies to increase inter-rater reliability and decrease missing data are described. DISCUSSION: The TTM2-trial follow-up is a pragmatic yet detailed pre-planned and standardised assessment of patient's outcome designed to ensure data-quality, decrease missing data and provide optimal conditions to investigate clinically relevant effects of TTM, including OHCA-survivors' neurocognitive function and societal participation.

Adult Critical Care University Hospital of Wales Cardiff United Kingdom

Australian and New Zealand Intensive Care Research Centre School of Epidemiology and Preventive Medicine Monash University Melbourne Australia

Bankstown Hospital South Western Sydney Local Health District Sydney Australia; Critical Care Division The George Institute for Global Health University of New South Wales Sydney Australia

Clinical Studies Sweden Forum South Skane University Hospital Lund Sweden

Cochin University Hospital and Paris Descartes University Paris France

Copenhagen Trial Unit Copenhagen Department of Regional Health Research The Faculty of Health Sciences University of Southern Denmark Department of Cardiology Holbæk Hospital Copenhagen Denmark

Department of Anaesthesiology and Intensive Care Medicine Institute of Clinical Sciences Sahlgrenska Academy University of Gothenburg and Sahlgrenska University Hospital Gothenburg Sweden

Department of Anesthesiology Rikshospitalet Oslo University Hospital Oslo Norway

Department of Emergency Medicine University of Pittsburgh Pittsburgh PA USA

Department of Intensive Care Medicine CHUV Lausanne University Hospital and University of Lausanne Lausanne Switzerland

Department of Medicine Center for Resuscitation Science Karolinska Institute Solna Sweden

Department of Medicine Department of Cardiovascular Medicine Faculty of Medicine Charles University and General University Hospital Prague Prague Czech Republic

Department of Neurology Charité University Medicine Berlin Germany

Department of Neurology Neurological Intensive Care Unit Medical University Innsbruck Innsbruck Austria

Department of Surgical Sciences and Integrated Diagnostics University of Genoa Genoa Italy; San Martino Policlinico Hospital IRCCS for Oncology and Neurosciences Genoa Italy

Erasme Hospital Université Libre de Bruxelles Department of Intensive Care Brussels Belgium

Lund University Helsingborg Hospital Department of Clinical Sciences Lund Anesthesiology and Intensive Care Helsingborg Sweden

Lund University Skane University Hospital Department of Clinical Sciences Lund Anesthesiology and Intensive Care Malmö Sweden

Lund University Skane University Hospital Department of Clinical Sciences Lund Cardiology Lund Sweden

Lund University Skane University Hospital Department of Clinical Sciences Lund Neurology Lund Sweden

Lund University Skane University Hospital Department of Clinical Sciences Research and Education Lund Sweden

Medical Research Institute of New Zealand Wellington New Zealand

Research Center for Emergency Medicine Aarhus University Hospital and Aarhus University Aarhus Denmark

Citace poskytuje Crossref.org

Effects of Hypothermia vs Normothermia on Societal Participation and Cognitive Function at 6 Months in Survivors After Out-of-Hospital Cardiac Arrest: A Predefined Analysis of the TTM2 Randomized Clinical Trial

Biomarkers of brain injury after cardiac arrest; a statistical analysis plan from the TTM2 trial biobank investigators

Ventilation management and outcomes in out-of-hospital cardiac arrest: a protocol for a preplanned secondary analysis of the TTM2 trial

Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest: a statistical analysis plan