AI Article Synopsis
- - This study aims to investigate whether using the freshest available red blood cells (RBCs) instead of standard RBCs can lower mortality rates in critically ill ICU patients, making it the largest ongoing randomized controlled trial on this topic.
- - Conducted as a double-blind trial involving 5000 adult ICU patients across multiple countries, the study compares the effects of fresh RBC transfusions on various health outcomes, including 90-day all-cause mortality.
- - With a robust statistical plan in place for unbiased results, the TRANSFUSE trial is designed to potentially influence clinical practices and policies regarding blood transfusions in critical care, regardless of its findings.
Article 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.
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