Author: Sekela, Michael E. et al.
Anesthesiology. August 2025. doi:10.1097/ALN.0000000000005716
This Phase III, double-blind, non-inferiority trial (ReCePI) evaluated pathogen-reduced red blood cells (treated with amustaline/glutathione) compared to conventional transfusions in patients undergoing cardiac or thoracic-aorta surgery at high risk for red cell transfusion. The primary endpoint was the incidence of acute kidney injury (AKI) within 48 hours after surgery, defined as a ≥0.3 mg/dL rise in serum creatinine.
Among 581 randomized patients, 321 (55%) received transfusions. AKI occurred in 29.3% of patients in the pathogen-reduced group and 28.0% in the conventional group. The treatment difference (0.7%, 95% CI -8.9 to 10.4%) met the pre-specified non-inferiority margin. Hemoglobin nadir levels on day 3 were similar between groups, and overall AKI incidence by KDIGO criteria at 7 days did not differ, though stage III AKI was numerically higher with pathogen-reduced transfusion (9.4% vs. 4.3%, p=0.075). Five patients in the pathogen-reduced arm developed low-titer red cell antibodies, but none showed hemolysis.
What you should know:
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Pathogen-reduced red blood cells were non-inferior to conventional transfusions in terms of postoperative AKI.
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Hemoglobin outcomes were comparable between groups.
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Stage III AKI was numerically higher in the pathogen-reduced group, though not statistically significant.
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Rare low-titer antibodies developed in a few pathogen-reduced recipients, but without clinical hemolysis.
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Pathogen-reduction may improve transfusion safety without major loss of efficacy.
Thank you to Anesthesiology for allowing me to use this article.