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dc.contributor.authorJakobsen, Janus Christian-
dc.contributor.authorDankiewicz, Josef-
dc.contributor.authorLange, Theis-
dc.contributor.authorCronberg, Tobias-
dc.contributor.authorLilja, Gisela-
dc.contributor.authorLevin, Helena-
dc.contributor.authorBělohlávek, Jan-
dc.contributor.authorCallaway, Clifton-
dc.contributor.authorCariou, Alain-
dc.contributor.authorErlinge, David-
dc.contributor.authorHovdenes, Jan-
dc.contributor.authorJoannidis, Michael-
dc.contributor.authorNordberg, Per-
dc.contributor.authorOddo, Mauro-
dc.contributor.authorPelosi, Paolo-
dc.contributor.authorKirkegaard, Hans-
dc.contributor.authorEastwood, Glenn M-
dc.contributor.authorRylander, Christian-
dc.contributor.authorSaxena, Manoj-
dc.contributor.authorStorm, Christian-
dc.contributor.authorTaccone, Fabio Silvio-
dc.contributor.authorWise, Matthew P-
dc.contributor.authorMorgan, Matt P G-
dc.contributor.authorYoung, Paul-
dc.contributor.authorNichol, Alistair-
dc.contributor.authorFriberg, Hans-
dc.contributor.authorUllén, Susann-
dc.contributor.authorNielsen, Niklas-
dc.identifier.citationTrials 2020; 21(1): 831en
dc.description.abstractTo date, targeted temperature management (TTM) is the only neuroprotective intervention after resuscitation from cardiac arrest that is recommended by guidelines. The evidence on the effects of TTM is unclear. The Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest (TTM2) trial is an international, multicentre, parallel group, investigator-initiated, randomised, superiority trial in which TTM with a target temperature of 33 °C after cardiac arrest will be compared with a strategy to maintain normothermia and active treatment of fever (≥ 37.8 °C). Prognosticators, outcome assessors, the steering group, the trial coordinating team, and trial statisticians will be blinded to treatment allocation. The primary outcome will be all-cause mortality at 180 days after randomisation. We estimate a 55% mortality in the targeted normothermia group. To detect an absolute risk reduction of 7.5% with an alpha of 0.05 and 90% power, 1900 participants will be enrolled. The secondary neurological outcome will be poor functional outcome (modified Rankin scale 4-6) at 180 days after cardiac arrest. In this paper, a detailed statistical analysis plan is presented, including a comprehensive description of the statistical analyses, handling of missing data, and assessments of underlying statistical assumptions. Final analyses will be conducted independently by two qualified statisticians following the present plan. This SAP, which was prepared before completion of enrolment, should increase the validity of the TTM trial by mitigation of analysis-bias.en
dc.titleTargeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest: a statistical analysis plan.en
dc.typeJournal Articleen
dc.identifier.affiliationMedical Research Institute of New Zealand, Wellington, New Zealanden
dc.identifier.affiliationDepartment of Cardiology, Holbæk Hospital, Holbæk, Denmarken
dc.identifier.affiliationDepartment of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmarken
dc.identifier.affiliationDepartment of Surgical Sciences and Integrated Diagnostics (DISC), University of Genoa, Genoa, Italyen
dc.identifier.affiliationSan Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, University of Genoa, Genoa, Italyen
dc.identifier.affiliationDepartment of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, Berlin, Germanyen
dc.identifier.affiliationDivision of Neuroscience Critical Care, Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USAen
dc.identifier.affiliationIntensive Careen
dc.identifier.affiliationBankstown Hospital Clinical School and The George Institute for Global Health, University of New South Wales, Kensington, Australiaen
dc.identifier.affiliationUniversity Collage Dublin-Clinical Research Centre, St Vincent's University Hospital, Dublin, Irelanden
dc.identifier.affiliationAustralian and New Zealand Intensive Care-Research Centre, Monash University, Melbourne, Australiaen
dc.identifier.affiliationDepartment of Critical Care, Alfred Hospital, Melbourne, Australiaen
dc.identifier.affiliationDepartment of Clinical Sciences, Cardiology, Lund University, Skåne University Hospital, Lund, Swedenen
dc.identifier.affiliationCopenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Tagensvej 22, Copenhagen, Denmarken
dc.identifier.affiliationSection of Biostatistics, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmarken
dc.identifier.affiliationDepartment of Clinical Sciences, Neurology, Lund University, Skåne University Hospital, Lund, Swedenen
dc.identifier.affiliationDepartment of Clinical Sciences, Research and Education, Lund University, Skåne University Hospital, Lund, Swedenen
dc.identifier.affiliation2nd Department of Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republicen
dc.identifier.affiliationDepartment of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, USAen
dc.identifier.affiliationMedical Intensive Care Unit, Cochin University Hospital (APHP) and Paris Descartes University, Paris, Franceen
dc.identifier.affiliationDepartment of Clinical Sciences, Cardiology, Lund University, Skåne University Hospital, Lund, Swedenen
dc.identifier.affiliationDepartment of Anesthesia and Intensive Care, Oslo University Hospital, Rikshospitalet, Oslo, Norwayen
dc.identifier.affiliationDivision of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austriaen
dc.identifier.affiliationDepartment of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Swedenen
dc.identifier.affiliationDepartment of Intensive Care Medicine, Faculty of Biology and Medicine, Centre Hospitalier Universitaire Vaudois (CHUV) - University Hospital, University of Lausanne, Lausanne, Switzerlanden
dc.identifier.affiliationResearch Center for Emergency Medicine, Department of Clinical Medicine, Aarhus University Hospital and Aarhus University, Aarhus N, Denmarken
dc.identifier.affiliationDepartment of Anesthesiology and Intensive Care Medicine, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Swedenen
dc.identifier.affiliationDepartment of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles (ULB), Brussels, Belgiumen
dc.identifier.affiliationAdult Critical Care, University Hospital of Wales, Cardiff, UKen
dc.identifier.affiliationDepartment of Clinical Sciences, Anesthesia & Intensive Care, Lund University, Skåne University Hospital, Lund, Swedenen
dc.identifier.affiliationClinical Studies Sweden, Skåne University Hospital, Lund, Swedenen
dc.identifier.affiliationDepartment of Clinical Sciences Lund, Anesthesia & Intensive Care, Lund University, Helsingborg Hospital, Lund, Swedenen
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