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 |
Externí odkaz: |