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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)
G. Lilja, N. Nielsen, S. Ullén, E. Blennow Nordstrom, J. Dankiewicz, H. Friberg, K. Heimburg, JC. Jakobsen, H. Levin, C. Callaway, A. Cariou, GM. Eastwood, R. Helbok, J. Hovdenes, H. Kirkegaard, C. Leithner, MPG. Morgan, P. Nordberg, M. Oddo, P....
Language English Country Ireland
Document type Clinical Trial Protocol, Journal Article, Research Support, Non-U.S. Gov't
- MeSH
- Hypothermia * MeSH
- Humans MeSH
- Multicenter Studies as Topic MeSH
- Follow-Up Studies MeSH
- Randomized Controlled Trials as Topic MeSH
- Reproducibility of Results MeSH
- Aged MeSH
- Hypothermia, Induced * MeSH
- Treatment Outcome MeSH
- Out-of-Hospital Cardiac Arrest * therapy MeSH
- Check Tag
- Humans MeSH
- Aged MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Clinical Trial Protocol MeSH
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
Bankstown Hospital South Western Sydney Local Health District Sydney Australia
Clinical Studies Sweden Forum South Skane University Hospital Lund Sweden
Cochin University Hospital and Paris Descartes University Paris France
Department of Anesthesiology Rikshospitalet Oslo University Hospital Oslo Norway
Department of Emergency Medicine University of Pittsburgh Pittsburgh PA USA
Department of Medicine Center for Resuscitation Science Karolinska Institute Solna Sweden
Department of Neurology Charité University Medicine Berlin Germany
Department of Surgical Sciences and Integrated Diagnostics University of Genoa Genoa Italy
Erasme Hospital Université Libre de Bruxelles Department of Intensive Care Brussels Belgium
Lund University Skane University Hospital Department of Clinical Sciences Lund Neurology Lund Sweden
Medical Research Institute of New Zealand Wellington New Zealand
San Martino Policlinico Hospital IRCCS for Oncology and Neurosciences Genoa Italy
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