Red blood cells treated with the amustaline (S-303) pathogen reduction system: a transfusion study in cardiac surgery
| Autor: | Norman Huang, Iuliia Weber, Hans-Ulrich Pfeiffer, Erhard Seifried, Reinhard Henschler, Michael Schmidt, Anna Erickson, Johannes Leibacher, Laurence Corash, Christine Ernst, Richard J. Benjamin, Katharina Madlener, Sarah Dombos, Markus Müller, Nina Mufti, Veronika Brixner, AH Kiessling, Anne North, Salvador Rico, Christof Geisen |
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| Rok vydání: | 2018 |
| Předmět: |
medicine.medical_specialty
Immunology 030204 cardiovascular system & hematology Hematocrit Gastroenterology law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Internal medicine medicine Immunology and Allergy 030212 general & internal medicine Adverse effect medicine.diagnostic_test business.industry hemic and immune systems Hematology medicine.disease Hemolysis Cardiac surgery Red blood cell Amustaline medicine.anatomical_structure Hemoglobin business circulatory and respiratory physiology |
| Zdroj: | Transfusion. 58:905-916 |
| ISSN: | 0041-1132 |
| DOI: | 10.1111/trf.14528 |
| Popis: | Background Nucleic acid-targeted pathogen inactivation technology using amustaline (S-303) and glutathione (GSH) was developed to reduce the risk of transfusion-transmitted infectious disease and transfusion-associated graft-versus-host disease with red blood cell (RBC) transfusion. Study design and methods A randomized, double-blind, controlled study was performed to assess the in vitro characteristics of amustaline-treated RBCs (test) compared with conventional (control) RBCs and to evaluate safety and efficacy of transfusion during and after cardiac surgery. The primary device efficacy endpoint was the postproduction hemoglobin (Hb) content of RBCs. Exploratory clinical outcomes included renal and hepatic failure, the 6-minute walk test (a surrogate for cardiopulmonary function), adverse events (AEs), and the immune response to amustaline-treated RBCs. Results A total of 774 RBC unis were produced. Mean treatment difference in Hb content was -2.27 g/unit (95% confidence interval, -2.61 to -1.92 g/unit), within the prespecified equivalence margins (±5 g/unit) to declare noninferiority. Amustaline-treated RBCs met European guidelines for Hb content, hematocrit, and hemolysis. Fifty-one (25 test and 26 control) patients received study RBCs. There were no significant differences in RBC usage or other clinical outcomes. Observed AEs were within the spectrum expected for patients of similar age undergoing cardiovascular surgery requiring RBCs transfusion. No patients exhibited an immune response specific to amustaline-treated RBCs. Conclusion Amustaline-treated RBCs demonstrated equivalence to control RBCs for Hb content, have appropriate characteristics for transfusion, and were well tolerated when transfused in support of acute anemia. Renal impairment was characterized as a potential efficacy endpoint for pivotal studies of RBC transfusion in cardiac surgery. |
| Databáze: | OpenAIRE |
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