Investigation of whether the acute hemolysis associated with Rho(D) immune globulin intravenous (human) administration for treatment of immune thrombocytopenic purpura is consistent with the acute hemolytic transfusion reaction model

摘要: BACKGROUND: Immune thrombocytopenic purpura and secondary thrombocytopenia patients treated with Rho(D) immune globulin intravenous (human; anti-D IGIV) have experienced acute hemolysis, which is inconsistent the typical presentation of extravascular hemolysis—the presumed mechanism action IGIV. Although anti-D-IGIV–associated hemolysis has not been established, onset, signs/symptoms, complications appear consistent intravascular hemolytic transfusion reactions (AHTRs). In medicine, red blood cell (RBC) antigen-antibody incompatibility(-ies) that precipitate AHTRs can be detected in vitro compatibility testing. Under premise results from RBC antigen-antibody–mediated complement activation, this study evaluated whether could a hemolysin assay, would support AHTR model as mechanism. STUDY DESIGN AND METHODS: Seven IGIV lots were tested to determine antibody identities those lots, including four had implicated episodes. Hemolysin assays performed each 73 specimens against lot, RBCs one patient who after administration. RESULTS: Only two contained antibodies beyond expected. No endpoint was observed any assays. CONCLUSION: findings did model, are reported contribute knowledge about prompt continued investigation into cause(s), prediction, prevention potentially serious adverse event.