Effects of red-cell storage duration on patients undergoing cardiac surgery

Abstract

Background: Some observational studies have reported that transfusion of red-cell units that have been stored for more than 2 to 3 weeks is associated with serious, even fatal, adverse events. Patients undergoing cardiac surgery may be especially vulnerable to the adverse effects of transfusion.

Methods: We conducted a randomized trial at multiple sites from 2010 to 2014. Participants 12 years of age or older who were undergoing complex cardiac surgery and were likely to undergo transfusion of red cells were randomly assigned to receive leukocyte-reduced red cells stored for 10 days or less (shorter-term storage group) or for 21 days or more (longer-term storage group) for all intraoperative and postoperative transfusions. The primary outcome was the change in Multiple Organ Dysfunction Score (MODS; range, 0 to 24, with higher scores indicating more severe organ dysfunction) from the preoperative score to the highest composite score through day 7 or the time of death or discharge.

Results: The median storage time of red-cell units provided to the 1098 participants who received red-cell transfusion was 7 days in the shorter-term storage group and 28 days in the longer-term storage group. The mean change in MODS was an increase of 8.5 and 8.7 points, respectively (95% confidence interval for the difference, -0.6 to 0.3; P=0.44). The 7-day mortality was 2.8% in the shorter-term storage group and 2.0% in the longer-term storage group (P=0.43); 28-day mortality was 4.4% and 5.3%, respectively (P=0.57). Adverse events did not differ significantly between groups except that hyperbilirubinemia was more common in the longer-term storage group.

Conclusions: The duration of red-cell storage was not associated with significant differences in the change in MODS. We did not find that the transfusion of red cells stored for 10 days or less was superior to the transfusion of red cells stored for 21 days or more among patients 12 years of age or older who were undergoing complex cardiac surgery. (Funded by the National Heart, Lung, and Blood Institute; RECESS ClinicalTrials.gov number, NCT00991341.).

Figure 1. Storage Duration of Red-Cell Units, According to Study Group

The black dashed line indicates the distribution of storage durations for red-cell units transfused in participants who were randomly assigned to receive blood stored for 10 days or less, and the red line indicates the distribution of storage durations for red-cell units transfused in participants assigned to receive blood stored for 21 days or longer.

Figure 2. Between-Group Differences in 7-Day Change in MODS

All subgroup analyses, except for the analysis of group O versus other blood groups, age (≤65 years vs. >65 years), receipt of 8 or more units of red cells versus less than 8 units, and score on the Transfusion Risk Understanding Scoring Tool (TRUST) were prespecified in the protocol. Scores on the Multiple Organ Dysfunction Score (MODS) range from 0 to 24 points, with higher scores indicating more severe organ dysfunction. ΔMODS denotes the change in MODS. Race and ethnic group were self-reported. TRUST scores range from 0 to 8, with higher scores indicating a greater probability of red-cell transfusion. A TRUST score of 3 or higher corresponds to a likelihood of receiving a red-cell transfusion during surgery or on the first day after surgery of 60% or more.