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Title: | Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest: a statistical analysis plan. | Austin Authors: | Jakobsen, Janus Christian;Dankiewicz, Josef;Lange, Theis;Cronberg, Tobias;Lilja, Gisela;Levin, Helena;Bělohlávek, Jan;Callaway, Clifton;Cariou, Alain;Erlinge, David;Hovdenes, Jan;Joannidis, Michael;Nordberg, Per;Oddo, Mauro;Pelosi, Paolo;Kirkegaard, Hans;Eastwood, Glenn M ;Rylander, Christian;Saxena, Manoj;Storm, Christian;Taccone, Fabio Silvio;Wise, Matthew P;Morgan, Matt P G;Young, Paul;Nichol, Alistair;Friberg, Hans;Ullén, Susann;Nielsen, Niklas | Affiliation: | Medical Research Institute of New Zealand, Wellington, New Zealand Department of Cardiology, Holbæk Hospital, Holbæk, Denmark Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark Department of Surgical Sciences and Integrated Diagnostics (DISC), University of Genoa, Genoa, Italy San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, University of Genoa, Genoa, Italy Department of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, Berlin, Germany Division of Neuroscience Critical Care, Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA Intensive Care Bankstown Hospital Clinical School and The George Institute for Global Health, University of New South Wales, Kensington, Australia University Collage Dublin-Clinical Research Centre, St Vincent's University Hospital, Dublin, Ireland Australian and New Zealand Intensive Care-Research Centre, Monash University, Melbourne, Australia Department of Critical Care, Alfred Hospital, Melbourne, Australia Department of Clinical Sciences, Cardiology, Lund University, Skåne University Hospital, Lund, Sweden Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Tagensvej 22, Copenhagen, Denmark Section of Biostatistics, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark Department of Clinical Sciences, Neurology, Lund University, Skåne University Hospital, Lund, Sweden Department of Clinical Sciences, Research and Education, Lund University, Skåne University Hospital, Lund, Sweden 2nd Department of Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, USA Medical Intensive Care Unit, Cochin University Hospital (APHP) and Paris Descartes University, Paris, France Department of Clinical Sciences, Cardiology, Lund University, Skåne University Hospital, Lund, Sweden Department of Anesthesia and Intensive Care, Oslo University Hospital, Rikshospitalet, Oslo, Norway Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden Department of Intensive Care Medicine, Faculty of Biology and Medicine, Centre Hospitalier Universitaire Vaudois (CHUV) - University Hospital, University of Lausanne, Lausanne, Switzerland Research Center for Emergency Medicine, Department of Clinical Medicine, Aarhus University Hospital and Aarhus University, Aarhus N, Denmark Department of Anesthesiology and Intensive Care Medicine, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles (ULB), Brussels, Belgium Adult Critical Care, University Hospital of Wales, Cardiff, UK Department of Clinical Sciences, Anesthesia & Intensive Care, Lund University, Skåne University Hospital, Lund, Sweden Clinical Studies Sweden, Skåne University Hospital, Lund, Sweden Department of Clinical Sciences Lund, Anesthesia & Intensive Care, Lund University, Helsingborg Hospital, Lund, Sweden |
Issue Date: | 7-Oct-2020 | Date: | 2020-10-07 | Publication information: | Trials 2020; 21(1): 831 | Abstract: | To 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. | URI: | https://ahro.austin.org.au/austinjspui/handle/1/25053 | DOI: | 10.1186/s13063-020-04654-y | ORCID: | 0000-0002-3642-2120 | Journal: | Trials | PubMed URL: | 33028425 | Type: | Journal Article |
Appears in Collections: | Journal articles |
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