RESUMO
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.
Assuntos
Acridinas/farmacologia , Bacteriemia/prevenção & controle , Segurança do Sangue/métodos , Patógenos Transmitidos pelo Sangue , Procedimentos Cirúrgicos Cardíacos , Transfusão de Eritrócitos , Eritrócitos/efeitos dos fármacos , Compostos de Mostarda Nitrogenada/farmacologia , Viremia/prevenção & controle , Injúria Renal Aguda/etiologia , Idoso , Idoso de 80 Anos ou mais , Bacteriemia/transmissão , Patógenos Transmitidos pelo Sangue/efeitos dos fármacos , Método Duplo-Cego , Transfusão de Eritrócitos/efeitos adversos , Feminino , Glutationa/farmacologia , Doença Enxerto-Hospedeiro/prevenção & controle , Testes de Função Cardíaca , Hemoglobinas/análise , Humanos , Falência Hepática/etiologia , Masculino , Complicações Pós-Operatórias/etiologia , Reação Transfusional/prevenção & controle , Viremia/transmissão , Inativação de VírusRESUMO
We demonstrate for the first time to our knowledge intra-cavity frequency doubling (ICFD) of an edge-emitter diode laser using a 10 mm-long 5.0 microm periodically poled LiNbO(3) (PPLN) crystal. An optical output power of 33 mW second harmonic blue light at 490.5 nm is generated at 1.0 A injection current, equivalent to an overall wall-plug efficiency of 1.8%. The measured M(2) values of blue beam are 1.7 and 2.4 along the fast and slow axis.
Assuntos
Lasers Semicondutores , Nióbio/química , Dispositivos Ópticos , Óxidos/química , Algoritmos , Cristalização , Desenho de Equipamento , Lasers , Luz , Modelos Estatísticos , Dinâmica não Linear , Óptica e Fotônica , TemperaturaRESUMO
A compact green laser of 1.3 W output at 534.7 nm is generated by intracavity frequency doubling (ICFD) of a 49 edge-emitter laser bar using a MgO-doped (PPLN) bulk crystal. The measured M(2) values of green beam are 12.1 and 2.9 along the slow and fast axes, respectively. To our knowledge, this is the first demonstration of the ICFD of multi-edge-emitters laser bar.