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  • Jakobsen, Janus ChristianCopenhagen University Hospital,Holbæk Hospital,University of Southern Denmark (author)

Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest: a statistical analysis plan.

  • Article/chapterEnglish2020

Publisher, publication year, extent ...

  • 2020-10-07
  • Springer Science and Business Media LLC,2020

Numbers

  • LIBRIS-ID:oai:gup.ub.gu.se/296978
  • https://gup.ub.gu.se/publication/296978URI
  • https://doi.org/10.1186/s13063-020-04654-yDOI
  • https://lup.lub.lu.se/record/5d866364-5630-49fb-a929-65a80ca7cb69URI
  • http://kipublications.ki.se/Default.aspx?queryparsed=id:144890688URI

Supplementary language notes

  • Language:English

Part of subdatabase

Classification

  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • 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 180days 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 180days 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.

Subject headings and genre

Added entries (persons, corporate bodies, meetings, titles ...)

  • Dankiewicz, JosefLund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital(Swepub:lu)med-jfd (author)
  • Lange, TheisUniversity of Copenhagen (author)
  • Cronberg, TobiasLund University,Lunds universitet,Neurologi, Lund,Sektion IV,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Centrum för hjärtstopp,Forskargrupper vid Lunds universitet,Brain Injury After Cardiac Arrest,Neurology, Lund,Section IV,Department of Clinical Sciences, Lund,Faculty of Medicine,Center for cardiac arrest,Lund University Research Groups,Skåne University Hospital(Swepub:lu)efor-tcr (author)
  • Lilja, GiselaLund University,Lunds universitet,Neurologi, Lund,Sektion IV,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Centrum för hjärtstopp,Forskargrupper vid Lunds universitet,Brain Injury After Cardiac Arrest,Neurology, Lund,Section IV,Department of Clinical Sciences, Lund,Faculty of Medicine,Center for cardiac arrest,Lund University Research Groups,Skåne University Hospital(Swepub:lu)med-gal (author)
  • Levin, HelenaLund University,Lunds universitet,Anestesiologi och intensivvård,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Centrum för hjärtstopp,Forskargrupper vid Lunds universitet,Anesthesiology and Intensive Care,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Center for cardiac arrest,Lund University Research Groups,Skåne University Hospital(Swepub:lu)ores-hal (author)
  • Bělohlávek, JanGeneral University Hospital in Prague (author)
  • Callaway, CliftonUniversity of Pittsburgh (author)
  • Cariou, AlainCochin Hospital (author)
  • Erlinge, DavidLund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Molekylär kardiologi,Forskargrupper vid Lunds universitet,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Molecular Cardiology,Lund University Research Groups,Skåne University Hospital(Swepub:lu)kard-der (author)
  • Hovdenes, JanOslo university hospital (author)
  • Joannidis, MichaelMedical University of Innsbruck (author)
  • Nordberg, PerKarolinska Institutet,Karolinska Institute (author)
  • Oddo, MauroLausanne University Hospital (author)
  • Pelosi, PaoloUniversity of Genoa,Ospedale Policlinico San Martino,University Hospital of Wales (author)
  • Kirkegaard, HansAarhus University Hospital (author)
  • Eastwood, GlennAustin Hospital (author)
  • Rylander, Christian,1960Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för anestesiologi och intensivvård,Institute of Clinical Sciences, Department of Anesthesiology and Intensive care,Sahlgrenska Academy(Swepub:gu)xrylch (author)
  • Saxena, ManojUniversity of New South Wales (author)
  • Storm, ChristianJohns Hopkins University School of Medicine,Charité - University Medicine Berlin (author)
  • Taccone, Fabio SilvioUniversité Libre de Bruxelles (ULB) (author)
  • Wise, Matthew P (author)
  • Morgan, Matt P G (author)
  • Young, PaulMedical Research Institute of New Zealand (author)
  • Nichol, AlistairAlfred Hospital,St Vincent's University Hospital,Monash University (author)
  • Friberg, HansLund University,Lunds universitet,Anestesiologi och intensivvård,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Centrum för hjärtstopp,Forskargrupper vid Lunds universitet,SWECRIT,Anesthesiology and Intensive Care,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Center for cardiac arrest,Lund University Research Groups,Skåne University Hospital(Swepub:lu)efor-hfr (author)
  • Ullén, SusannSkåne University Hospital(Swepub:lu)su7040ul (author)
  • Nielsen, NiklasLund University,Lunds universitet,Anestesiologi och intensivvård,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Kliniska Vetenskaper, Helsingborg,Institutionen för kliniska vetenskaper, Lund,Centrum för hjärtstopp,Forskargrupper vid Lunds universitet,SEBRA Sepsis and Bacterial Resistance Alliance,Anesthesiology and Intensive Care,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Clinical Sciences, Helsingborg,Department of Clinical Sciences, Lund,Center for cardiac arrest,Lund University Research Groups,Helsingborg Hospital(Swepub:lu)med-nni (author)
  • Copenhagen University HospitalHolbæk Hospital (creator_code:org_t)

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  • In:Trials: Springer Science and Business Media LLC21:11745-6215

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