A randomised controlled trial of standard transfusion versus fresher red blood cell use in intensive care (TRANSFUSE): protocol and statistical analysis plan

Kirsi-Maija Kaukonen, Michael John Bailey, Bridget Ady, Cecile Aubron, Craig French, Dashiell Gantner, David Irving, Lynnette Joy Murray, Alistair Dualta Nichol, Ville Pettila, Zoe McQuilten, David James Cooper

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Objective: To determine if using freshest available rather than standard-issue red blood cells (RBCs) can reduce mortality in critically ill intensive care unit patients. Our study is the largest ongoing randomised controlled trial (RCT) of RBC age in critically ill patients and will help determine if the use of the freshest available RBCs should become standard policy for the critically ill. DESIGN, SETTING AND PARTICIPANTS: A double-blind, multicentre, Phase III RCT of 5000 adult ICU patients in Australia, New Zealand, Europe and the Middle East. INTERVENTIONS: Transfusion of the freshest available RBCs in place of standard-care RBCs until hospital discharge. MAIN OUTCOME MEASURES: The primary outcome measure is 90-day all-cause mortality. Secondary outcome measures are time to death, 28-day and 180-day mortality, persistent organ dysfunction combined with death, days alive and free of mechanical ventilation and renal replacement therapy, bloodstream infection in the ICU, length of stay in the ICU and in hospital, proportion of patients with febrile non-haemolytic transfusion reactions, and quality of life at Day 180. RESULTS: A detailed statistical analysis plan with predefined subgroups and secondary analyses has been finalised before results being available, to ensure an unbiased final analysis. CONCLUSIONS: The pragmatic protocol design has been chosen to facilitate translation of the trial results into practice. The TRANSFUSE trial will have important clinical and policy implications, regardless of the outcome.
Original languageEnglish
Pages (from-to)255 - 261
Number of pages7
JournalCritical Care and Resuscitation
Volume16
Issue number4
Publication statusPublished - 2014

Cite this

@article{dd6f40ad11c74d349bdbeba574a1876e,
title = "A randomised controlled trial of standard transfusion versus fresher red blood cell use in intensive care (TRANSFUSE): protocol and statistical analysis plan",
abstract = "Objective: To determine if using freshest available rather than standard-issue red blood cells (RBCs) can reduce mortality in critically ill intensive care unit patients. Our study is the largest ongoing randomised controlled trial (RCT) of RBC age in critically ill patients and will help determine if the use of the freshest available RBCs should become standard policy for the critically ill. DESIGN, SETTING AND PARTICIPANTS: A double-blind, multicentre, Phase III RCT of 5000 adult ICU patients in Australia, New Zealand, Europe and the Middle East. INTERVENTIONS: Transfusion of the freshest available RBCs in place of standard-care RBCs until hospital discharge. MAIN OUTCOME MEASURES: The primary outcome measure is 90-day all-cause mortality. Secondary outcome measures are time to death, 28-day and 180-day mortality, persistent organ dysfunction combined with death, days alive and free of mechanical ventilation and renal replacement therapy, bloodstream infection in the ICU, length of stay in the ICU and in hospital, proportion of patients with febrile non-haemolytic transfusion reactions, and quality of life at Day 180. RESULTS: A detailed statistical analysis plan with predefined subgroups and secondary analyses has been finalised before results being available, to ensure an unbiased final analysis. CONCLUSIONS: The pragmatic protocol design has been chosen to facilitate translation of the trial results into practice. The TRANSFUSE trial will have important clinical and policy implications, regardless of the outcome.",
author = "Kirsi-Maija Kaukonen and Bailey, {Michael John} and Bridget Ady and Cecile Aubron and Craig French and Dashiell Gantner and David Irving and Murray, {Lynnette Joy} and Nichol, {Alistair Dualta} and Ville Pettila and Zoe McQuilten and Cooper, {David James}",
year = "2014",
language = "English",
volume = "16",
pages = "255 -- 261",
journal = "Critical Care and Resuscitation",
issn = "1441-2772",
publisher = "Australasian Medical Publishing Co. Pty Ltd. (AMPCo)",
number = "4",

}

TY - JOUR

T1 - A randomised controlled trial of standard transfusion versus fresher red blood cell use in intensive care (TRANSFUSE): protocol and statistical analysis plan

AU - Kaukonen, Kirsi-Maija

AU - Bailey, Michael John

AU - Ady, Bridget

AU - Aubron, Cecile

AU - French, Craig

AU - Gantner, Dashiell

AU - Irving, David

AU - Murray, Lynnette Joy

AU - Nichol, Alistair Dualta

AU - Pettila, Ville

AU - McQuilten, Zoe

AU - Cooper, David James

PY - 2014

Y1 - 2014

N2 - Objective: To determine if using freshest available rather than standard-issue red blood cells (RBCs) can reduce mortality in critically ill intensive care unit patients. Our study is the largest ongoing randomised controlled trial (RCT) of RBC age in critically ill patients and will help determine if the use of the freshest available RBCs should become standard policy for the critically ill. DESIGN, SETTING AND PARTICIPANTS: A double-blind, multicentre, Phase III RCT of 5000 adult ICU patients in Australia, New Zealand, Europe and the Middle East. INTERVENTIONS: Transfusion of the freshest available RBCs in place of standard-care RBCs until hospital discharge. MAIN OUTCOME MEASURES: The primary outcome measure is 90-day all-cause mortality. Secondary outcome measures are time to death, 28-day and 180-day mortality, persistent organ dysfunction combined with death, days alive and free of mechanical ventilation and renal replacement therapy, bloodstream infection in the ICU, length of stay in the ICU and in hospital, proportion of patients with febrile non-haemolytic transfusion reactions, and quality of life at Day 180. RESULTS: A detailed statistical analysis plan with predefined subgroups and secondary analyses has been finalised before results being available, to ensure an unbiased final analysis. CONCLUSIONS: The pragmatic protocol design has been chosen to facilitate translation of the trial results into practice. The TRANSFUSE trial will have important clinical and policy implications, regardless of the outcome.

AB - Objective: To determine if using freshest available rather than standard-issue red blood cells (RBCs) can reduce mortality in critically ill intensive care unit patients. Our study is the largest ongoing randomised controlled trial (RCT) of RBC age in critically ill patients and will help determine if the use of the freshest available RBCs should become standard policy for the critically ill. DESIGN, SETTING AND PARTICIPANTS: A double-blind, multicentre, Phase III RCT of 5000 adult ICU patients in Australia, New Zealand, Europe and the Middle East. INTERVENTIONS: Transfusion of the freshest available RBCs in place of standard-care RBCs until hospital discharge. MAIN OUTCOME MEASURES: The primary outcome measure is 90-day all-cause mortality. Secondary outcome measures are time to death, 28-day and 180-day mortality, persistent organ dysfunction combined with death, days alive and free of mechanical ventilation and renal replacement therapy, bloodstream infection in the ICU, length of stay in the ICU and in hospital, proportion of patients with febrile non-haemolytic transfusion reactions, and quality of life at Day 180. RESULTS: A detailed statistical analysis plan with predefined subgroups and secondary analyses has been finalised before results being available, to ensure an unbiased final analysis. CONCLUSIONS: The pragmatic protocol design has been chosen to facilitate translation of the trial results into practice. The TRANSFUSE trial will have important clinical and policy implications, regardless of the outcome.

UR - http://www.ncbi.nlm.nih.gov/pubmed/25437218

M3 - Article

VL - 16

SP - 255

EP - 261

JO - Critical Care and Resuscitation

JF - Critical Care and Resuscitation

SN - 1441-2772

IS - 4

ER -