Blood safety study: do antibodies to treated red cells cause harm?

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥4 years in children who meet the requirement of US Code of Federal Regulation (CFR) Title 21, §50.53 as determined by the local Institutional Review Board (IRB). * Control subjects shall have no current or previously documented antibodies to INTERCEPT RBC. * Test subjects shall have current or previously documented natural or treatment-emergent antibodies to INTERCEPT RBCs. * History of prior transfusion with allogeneic blood products (INTERCEPT or non-INTERCEPT treated). * \>120 days from the subjects most recent exposure to Study RBCs (pathogen reduced or non-pathogen reduced - if any) prior to the planned study transfusion. * Signed and dated informed consent form Exclusion Criteria: * Foreseeable active blood loss due to trauma, surgery, or pathologic condition during the study period. * Exposure to another interventional drug or device in a clinical study within 28 days prior to enrollment or concurrently during the study. * Positive Direct Antiglobulin Test (≥2+) at the time of screening, prior to the first study transfusion. * Current or historical medical conditions judged by the Investigator to significantly increase the risk of morbidity/mortality due to hemolysis or the medical management of acute hemolysis. * Treatment with any medication known to affect RBC viability at the time of enrollment (e.g., ribavirin, sulfa drugs, chemotherapy medications, methylene blue, dapsone, levodopa, methyldopa, nitrofurantoin and its derivatives, phenazopyridine, quinidine, and hydantoins) * History of or development of a drug-associated RBC antibody not associated with INTERCEPT RBCs. * Congenital or acquired immunodeficiency judged by the Investigator to potentially impact the humoral immune response. * Immunosuppressive therapy within 1 month prior to enrollment or during the study period, including steroids and intravenous immunoglobulin. * Current or historical RBC alloantibodies that are judged by the Investigator to prevent selection of antigen-negative RBCs for transfusion. * History of immunoglobulin A (IgA) deficiency, severe allergic reaction to blood product(s), or clinical requirement to receive washed cellular products. * History of warm autoantibody with hemolysis. * Subjects who are pregnant, or biologically able to become pregnant and unwilling to remain on medically accepted contraception during this study.