Authors: Sekela, Michael E. et al.
Anesthesiology, August 12, 2025. DOI: 10.1097/ALN.0000000000005716
This multicenter phase III clinical trial, known as the Red Cell Pathogen Inactivation (ReCePI) study, evaluated the safety and efficacy of amustaline/glutathione pathogen-reduced red blood cells compared with conventional red cells for transfusion support in high-risk cardiac and thoracic-aortic surgery patients. The study specifically tested whether pathogen-reduced red cells were non-inferior in terms of postoperative kidney function while providing comparable transfusion efficacy and safety.
A total of 581 patients were randomized, and 321 (55%) received transfusions with either pathogen-reduced or conventional red cells during surgery and up to seven days postoperatively. The primary endpoint was acute kidney injury (AKI), defined as an increase in serum creatinine of at least 0.3 mg/dL within 48 hours after surgery.
AKI occurred in 29.3% of patients who received pathogen-reduced red cells versus 28.0% in the conventional transfusion group, meeting the prespecified non-inferiority criterion (treatment difference 0.7%, 95% CI –8.9 to 10.4%, P=0.001 for non-inferiority). Secondary outcomes, including hemoglobin levels and 7-day AKI rates based on KDIGO staging, were also similar between groups, although stage III AKI was slightly more frequent in the pathogen-reduced group (9.4% vs. 4.3%, P=0.075). Five recipients (3.1%) of pathogen-reduced blood developed low-titer red cell antibodies, but none experienced hemolysis or clinical sequelae.
These results demonstrate that pathogen-reduced red cells provide effective transfusion support comparable to standard units, without increasing kidney injury risk or significant immune complications.
What You Should Know:
Pathogen-reduced red blood cells using the amustaline/glutathione process were non-inferior to conventional units in preventing AKI after major cardiac or thoracic-aortic surgery. This technology offers the potential to enhance transfusion safety by reducing infectious and immunologic risks without compromising efficacy.
Thank you to Anesthesiology for publishing this pivotal trial advancing transfusion medicine and patient safety in the perioperative setting.