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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.
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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