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Protocol for outcome reporting and follow-up in the Targeted Hypothermia versus Targeted Normothermia after Out-of-Hospital Cardiac Arrest trial (TTM2)

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DOI

  • Gisela Lilja, Lund University
  • ,
  • Niklas Nielsen, Lund University
  • ,
  • Susann Ullén, Lund University
  • ,
  • Erik Blennow Nordstrom, Lund University
  • ,
  • Josef Dankiewicz, Lund University
  • ,
  • Hans Friberg, Lund University
  • ,
  • Katarina Heimburg, Lund University
  • ,
  • Janus Christian Jakobsen, University of Southern Denmark
  • ,
  • Helena Levin, Lunds Universitet
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  • Clifton Callaway, University of Pittsburgh
  • ,
  • Alain Cariou, Paris Descartes University
  • ,
  • Glenn M. Eastwood, Monash University
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  • Raimund Helbok, Innsbruck Medical University
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  • Jan Hovdenes, University of Oslo
  • ,
  • Hans Kirkegaard
  • Christoph Leithner, Charité – Universitätsmedizin Berlin
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  • Matt P.G. Morgan, University Hospital of Wales
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  • Per Nordberg, Karolinska Institutet
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  • Mauro Oddo, University of Lausanne
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  • Paolo Pelosi, University of Genoa, IRCCS San Martino-IST
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  • Christian Rylander, University of Gothenburg, Sahlgrenska University Hospital
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  • Manoj Saxena, Bankstown Hospital, University of New South Wales
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  • Fabio Silvio Taccone, Université Libre de Bruxelles
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  • Michal Siranec, Charles University
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  • Matthew P. Wise, University Hospital of Wales
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  • Paul J. Young, Medical Research Institute of New Zealand
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  • Tobias Cronberg, Lund University

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.

Original languageEnglish
JournalResuscitation
Volume150
Pages (from-to)104-112
Number of pages9
ISSN0300-9572
DOIs
Publication statusPublished - May 2020

    Research areas

  • Cardiac arrest, Cognitive function, Patient Reported Outcome Measures, Quality of life, Treatment outcome

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