Kirsi-Maija Kaukonen1, Michael Bailey2, Bridget Ady2, Cecile Aubron2, Craig French3, Dashiell Gantner2, David Irving4, Lynne Murray2, Alistair Nichol2, Ville Pettilä5, Zoe McQuilten2, D Jamie Cooper2. 1. Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia. maija.kaukonen@monash.edu. 2. Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia. 3. Intensive Care Unit, Western Health, Melbourne, VIC, Australia. 4. Research and Development, Australian Red Cross Blood Service, Sydney, NSW, Australia. 5. Intensive Care Units, Division of Anaesthesiology and Intensive Care Medicine, Helsinki University Central Hospital, Helsinki, Finland.
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.
RCT Entities:
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.
Authors: Steven B Solomon; Irene Cortés-Puch; Junfeng Sun; Kenneth E Remy; Dong Wang; Jing Feng; Sameena S Khan; Derek Sinchar; Daniel B Kim-Shapiro; Harvey G Klein; Charles Natanson Journal: Transfusion Date: 2015-07-15 Impact factor: 3.157
Authors: Irene Cortés-Puch; Kenneth E Remy; Steven B Solomon; Junfeng Sun; Dong Wang; Mariam Al-Hamad; Seth M Kelly; Derek Sinchar; Landon Bellavia; Tamir Kanias; Mark A Popovsky; Daniel B Kim-Shapiro; Harvey G Klein; Charles Natanson Journal: Transfusion Date: 2015-09-07 Impact factor: 3.157
Authors: Kirsi-Maija Kaukonen; Suvi T Vaara; Ville Pettilä; Rinaldo Bellomo; Jarno Tuimala; David J Cooper; Tom Krusius; Anne Kuitunen; Matti Reinikainen; Juha Koskenkari; Ari Uusaro Journal: Crit Care Date: 2013-10-04 Impact factor: 9.097