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

Autor: Shirley Vallance, Dashiell Gantner, Colin McArthur, Gilles Capellier, Tony Smith, Jeffrey J. Presneill, Alistair Nichol, Lynnette Murray, Dinesh Varma, Jessica Kasza, D. James Cooper, Tony Walker, Stephen Bernard, Jeffrey V. Rosenfeld, Tony Trapani, Steve Webb, Peter Cameron, Lynette Newby, Michael Stephenson, Olivier Huet, Stephen Rashford, Andrew Forbes
Rok vydání: 2017
Předmět:
Male
Time Factors
Medicine (miscellaneous)
Hypothermia
01 natural sciences
law.invention
010104 statistics & probability
Disability Evaluation
0302 clinical medicine
Statistical Analysis Plan
Traumatic brain injury
Randomized controlled trial
Quality of life
law
Hypothermia
Induced
Brain Injuries
Traumatic
Multicenter Studies as Topic
Pharmacology (medical)
030212 general & internal medicine
Prospective Studies
Randomized Controlled Trials as Topic
Outcome
Neurologic Examination
lcsh:R5-920
Glasgow Outcome Scale
Absolute risk reduction
Middle Aged
3. Good health
Europe
Treatment Outcome
Data Interpretation
Statistical
Female
lcsh:Medicine (General)
Cooling
Adult
medicine.medical_specialty
Adolescent
Randomised controlled trials
Update
03 medical and health sciences
Middle East
Young Adult
medicine
Humans
Glasgow Coma Scale
0101 mathematics
business.industry
Australia
Recovery of Function
medicine.disease
Clinical trial
Critical care
Clinical Trials
Phase III as Topic
Relative risk
Emergency medicine
business
New Zealand
Zdroj: Trials
Trials, Vol 19, Iss 1, Pp 1-10 (2018)
ISSN: 1745-6215
Popis: Background 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. Methods 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. Discussion 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. Trial registration ClinicalTrials.gov, NCT00987688 (first posted 1 October 2009); Australian New Zealand Clinical Trials Registry, ACTRN12609000764235. Registered on 3 September 2009. Electronic supplementary material The online version of this article (10.1186/s13063-018-2610-y) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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