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Statistical analysis plan for the POLAR-RCT: The Prophylactic hypOthermia trial to Lessen trAumatic bRain injury-Randomised Controlled Trial

Overview of attention for article published in Trials, April 2018
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Title
Statistical analysis plan for the POLAR-RCT: The Prophylactic hypOthermia trial to Lessen trAumatic bRain injury-Randomised Controlled Trial
Published in
Trials, April 2018
DOI 10.1186/s13063-018-2610-y
Pubmed ID
Authors

Jeffrey Presneill, Dashiell Gantner, Alistair Nichol, Colin McArthur, Andrew Forbes, Jessica Kasza, Tony Trapani, Lynnette Murray, Stephen Bernard, Peter Cameron, Gilles Capellier, Olivier Huet, Lynette Newby, Stephen Rashford, Jeffrey V. Rosenfeld, Tony Smith, Michael Stephenson, Dinesh Varma, Shirley Vallance, Tony Walker, Steve Webb, D. James Cooper

Abstract

The Prophylactic hypOthermia to Lessen trAumatic bRain injury-Randomised Controlled Trial (POLAR-RCT) will evaluate whether early and sustained prophylactic hypothermia delivered to patients with severe traumatic brain injury improves patient-centred outcomes. The POLAR-RCT is a multicentre, randomised, parallel group, phase III trial of early, prophylactic cooling in critically ill patients with severe traumatic brain injury, conducted in Australia, New Zealand, France, Switzerland, Saudi Arabia and Qatar. A total of 511 patients aged 18-60 years have been enrolled with severe acute traumatic brain injury. The trial intervention of early and sustained prophylactic hypothermia to 33 °C for 72 h will be compared to standard normothermia maintained at a core temperature of 37 °C. The primary outcome is the proportion of favourable neurological outcomes, comprising good recovery or moderate disability, observed at six months following randomisation utilising a midpoint dichotomisation of the Extended Glasgow Outcome Scale (GOSE). Secondary outcomes, also assessed at six months following randomisation, include the probability of an equal or greater GOSE level, mortality, the proportions of patients with haemorrhage or infection, as well as assessment of quality of life and health economic outcomes. The planned sample size will allow 80% power to detect a 30% relative risk increase from 50% to 65% (equivalent to a 15% absolute risk increase) in favourable neurological outcome at a two-sided alpha of 0.05. Consistent with international guidelines, a detailed and prospective analysis plan has been developed for the POLAR-RCT. This plan specifies the statistical models for evaluation of primary and secondary outcomes, as well as defining covariates for adjusted analyses and methods for exploratory analyses. Application of this statistical analysis plan to the forthcoming POLAR-RCT trial will facilitate unbiased analyses of these important clinical data. ClinicalTrials.gov, NCT00987688 (first posted 1 October 2009); Australian New Zealand Clinical Trials Registry, ACTRN12609000764235 . Registered on 3 September 2009.

Twitter Demographics

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Mendeley readers

The data shown below were compiled from readership statistics for 86 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 86 100%

Demographic breakdown

Readers by professional status Count As %
Researcher 10 12%
Student > Bachelor 10 12%
Student > Ph. D. Student 9 10%
Student > Master 9 10%
Other 6 7%
Other 15 17%
Unknown 27 31%
Readers by discipline Count As %
Medicine and Dentistry 24 28%
Nursing and Health Professions 15 17%
Psychology 5 6%
Sports and Recreations 3 3%
Engineering 3 3%
Other 8 9%
Unknown 28 33%

Attention Score in Context

This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 19 March 2019.
All research outputs
#12,148,826
of 15,937,496 outputs
Outputs from Trials
#3,217
of 4,212 outputs
Outputs of similar age
#193,537
of 279,374 outputs
Outputs of similar age from Trials
#1
of 1 outputs
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