1.
Effects of red-cell storage duration on patients undergoing cardiac surgery
Steiner ME, Ness PM, Assmann SF, Triulzi DJ, Sloan SR, Delaney M, Granger S, Bennett-Guerrero E, Blajchman MA, Scavo V, et al
New England Journal of Medicine. 2015;372((15):):1419-29.
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.).
2.
Randomized trial results: red cell storage age is not associated with a significant difference in multiple-organ dysfunction score or mortality in transfused cardiac surgery patients
Steiner ME, Triulzi DJ, Assmann SF, Sloan SR, Delaney M, Blajchman MA, Granger S, D'Andrea PA, Pulkrabek S, Stowell CP
Transfusion. 2014;54((S2)):15A.. Abstract No. P2-030A.
3.
A comparison of aprotinin and lysine analogues in high-risk cardiac surgery
Fergusson DA, Hébert PC, Mazer CD, Fremes S, MacAdams C, Murkin JM, Teoh K, Duke PC, Arellano R, Blajchman MA, et al
The New England Journal of Medicine. 2008;358((22):):2319-31.
Abstract
BACKGROUND Antifibrinolytic agents are commonly used during cardiac surgery to minimize bleeding and to reduce exposure to blood products. We sought to determine whether aprotinin was superior to either tranexamic acid or aminocaproic acid in decreasing massive postoperative bleeding and other clinically important consequences. METHODS In this multicenter, blinded trial, we randomly assigned 2331 high-risk cardiac surgical patients to one of three groups: 781 received aprotinin, 770 received tranexamic acid, and 780 received aminocaproic acid. The primary outcome was massive postoperative bleeding. Secondary outcomes included death from any cause at 30 days. RESULTS The trial was terminated early because of a higher rate of death in patients receiving aprotinin. A total of 74 patients (9. 5%) in the aprotinin group had massive bleeding, as compared with 93 (12. 1%) in the tranexamic acid group and 94 (12. 1%) in the aminocaproic acid group (relative risk in the aprotinin group for both comparisons, 0. 79; 95% confidence interval [CI], 0. 59 to 1. 05). At 30 days, the rate of death from any cause was 6. 0% in the aprotinin group, as compared with 3. 9% in the tranexamic acid group (relative risk, 1. 55; 95% CI, 0. 99 to 2. 42) and 4. 0% in the aminocaproic acid group (relative risk, 1. 52; 95% CI, 0. 98 to 2. 36). The relative risk of death in the aprotinin group, as compared with that in both groups receiving lysine analogues, was 1. 53 (95% CI, 1. 06 to 2. 22). CONCLUSIONS Despite the possibility of a modest reduction in the risk of massive bleeding, the strong and consistent negative mortality trend associated with aprotinin, as compared with the lysine analogues, precludes its use in high-risk cardiac surgery. (Current Controlled Trials number, ISRCTN15166455 [controlled-trials. com]. ).
4.
Avoiding transfusions in children undergoing cardiac surgery: a meta-analysis of randomized trials of aprotinin
Arnold DM, Fergusson DA, Chan AK, Cook RJ, Fraser GA, Lim W, Blajchman MA, Cook DJ
Anesthesia and Analgesia. 2006;102((3):):731-737.