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- Title
Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest: a statistical analysis plan.
- 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; Rylander, Christian; Saxena, Manoj; Storm, Christian
- Abstract
<bold>Background: </bold>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.<bold>Methods/design: </bold>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.<bold>Discussion: </bold>This SAP, which was prepared before completion of enrolment, should increase the validity of the TTM trial by mitigation of analysis-bias.
- Subjects
CARDIAC arrest; STATISTICS; HYPOTHERMIA; CARDIAC resuscitation; AUTOMATED external defibrillation; STATISTICIANS
- Publication
Trials, 2020, Vol 21, Issue 1, pN.PAG
- ISSN
1745-6215
- Publication type
journal article
- DOI
10.1186/s13063-020-04654-y