Selected article for: "clinical trial and program product"

Author: Kleinman, Steve; Stassinopoulos, Adonis
Title: Risks associated with red blood cell transfusions: potential benefits from application of pathogen inactivation
  • Document date: 2015_8_25
  • ID: qlddzgbg_30
    Snippet: Despite these encouraging observations, concerns still exist regarding alloantibody formation due to RBC alterations caused by second-generation S-303 treatment. Thus, a primary aim of the second-generation S-303 thalassemia clinical trial is to monitor RBC immunogenicity. However, given the small size of any clinical trial, negative results will not be sufficient to resolve this issue. This will require an ongoing hemovigilance program to monito.....
    Document: Despite these encouraging observations, concerns still exist regarding alloantibody formation due to RBC alterations caused by second-generation S-303 treatment. Thus, a primary aim of the second-generation S-303 thalassemia clinical trial is to monitor RBC immunogenicity. However, given the small size of any clinical trial, negative results will not be sufficient to resolve this issue. This will require an ongoing hemovigilance program to monitor routinely used product (as has been done for PI-PLTs and PI-plasma) [136] [137] [138] [139] to achieve the numbers required to assess this potential transfusion complication. Similar clinical trial endpoints and hemovigilance monitoring will be required to determine if the riboflavin system affects RBC immunogenicity.

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