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

Details

Serval ID
serval:BIB_D5BA560C31AF
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest: a statistical analysis plan.
Journal
Trials
Author(s)
Jakobsen J.C., Dankiewicz J., Lange T., Cronberg T., Lilja G., Levin H., Bělohlávek J., Callaway C., Cariou A., Erlinge D., Hovdenes J., Joannidis M., Nordberg P., Oddo M., Pelosi P., Kirkegaard H., Eastwood G., Rylander C., Saxena M., Storm C., Taccone F.S., Wise M.P., Morgan MPG, Young P., Nichol A., Friberg H., Ullén S., Nielsen N.
ISSN
1745-6215 (Electronic)
ISSN-L
1745-6215
Publication state
Published
Issued date
07/10/2020
Peer-reviewed
Oui
Volume
21
Number
1
Pages
831
Language
english
Notes
Publication types: Journal Article
Publication Status: epublish
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.
Pubmed
Web of science
Open Access
Yes
Create date
26/10/2020 8:41
Last modification date
07/07/2021 6:36
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