Transfusion Medicine and Hemostasis Clinical Trial Network (TMH CTN) - Red Cell Storage Duration Study (RECESS)
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January 2010 – March 2014
August 4, 2021
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Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
To compare clinical outcomes after cardiac surgery in patients who received transfused red cells stored for 10 days or less or for 21 days or more.
The objective of red-cell transfusion is to improve clinical outcomes. Since red cells undergo numerous changes during storage, multiple studies have assessed the association between the duration of red-cell storage and patient outcomes. Patients who have cardiac surgery often receive multiple units of red cells and may be especially vulnerable to end-organ injury because of compromised cardiac output. Several retrospective studies of the effect of the duration of red-cell storage in patients undergoing cardiac surgery have been conducted with differing results. Therefore, the Red-Cell Storage Duration Study (RECESS) was initiated to compare clinical outcomes after cardiac surgery in patients who received transfused red cells stored for 10 days or less or for 21 days or more.
Participants were required to be 12 years of age or older, weigh 40 kg or more, and be scheduled for complex cardiac surgery with planned median sternotomy. Patients 18 years of age or older were also required to have a score of 3 or higher on the Transfusion Risk Understanding Scoring Tool (TRUST), which corresponds to a likelihood of receiving a red-cell transfusion during surgery or on the first day after surgery of 60% or more.
A total of 1481 individuals underwent randomization; 538 participants randomized to the group receiving red-cell units stored for 10 days or less (shorter-term storage group) met the criteria for evaluation and 560 participants randomized to the group receiving red-cell units stored for 21 days or more (longer-term storage group) met the criteria for evaluation.
RECESS was a multicenter, prospective, randomized clinical trial. Participants were randomly assigned, in a 1:1 ratio, to receive red-cell units stored for 10 days or less or red-cell units stored for 21 days or more for all transfusions from randomization through postoperative day 28, hospital discharge, or death, whichever occurred first. Randomization was stratified according to age (<18 years vs. ≥18 years) and status with respect to admission to the intensive care unit (ICU) at the time of randomization. Patients met the criteria for evaluation if they underwent cardiac surgery within 30 days after randomization and received at least one red-cell transfusion between randomization and postoperative hour 96. Although only the transfusion service was aware of each participant’s assigned treatment, the expiration dates on the red-cell units were not obscured, in accordance with regulatory requirements.
Data were collected on all serious adverse events through post-operative day 7, hospital discharge, or death, whichever occurred first. Participants were followed for all-cause mortality until post-operative day 28, death, or study withdrawal, whichever occurred first.
The primary outcome was the change in the Multiple Organ Dysfunction Score (MODS; range, 0 to 24 points, with higher scores indicating more severe organ dysfunction) from the preoperative baseline through postoperative day 7, hospital discharge, or death, whichever occurred first. The 7-day MODS was calculated as the sum of the worst postoperative scores from each of the six organ systems included, even if a subject's worst values for different components occurred on different dates. Subjects who died during this time period were assigned the worst possible follow-up MODS score, 24 points.
The results of this study do not support the preferential transfusion of red cells with shorter storage periods in patients 12 years of age or older who are undergoing complex cardiac surgery.
Steiner ME, Ness PM, Assmann SF, et al. Effects of red-cell storage duration on patients undergoing cardiac surgery. N Engl J Med. 2015;372(15):1419-1429. doi:10.1056/NEJMoa1414219
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