This study aims to determine whether transfusion of INTERCEPT RBCs into patients with pre-existing antibodies to INTERCEPT RBCs will result in increased antibody titer indicative of a secondary immune response, and whether these immune responses would be associated with clinical adverse events, increased RBC clearance, and/or evidence of hemolysis. Because the recovery and survival of fresh allogeneic INTERCEPT RBCs in patients with a diverse group of diseases is poorly characterized, a Control group of subjects without a history or evidence of antibodies to INTERCEPT RBCs may be evaluated as a comparator (Control group subjects may or may not have previously been transfused with INTERCEPT RBCs).
The study will also compare and correlate results from anti-human globulin (AHG) crossmatch using INTERCEPT RBCs prepared for transfusion, with results from indirect antiglobulin testing (IAT) with S 303 treated reagent RBCs (i.e., INTERCEPT RBC screening assay, as used in previous studies) to assess the utility of the AHG crossmatch to define the compatibility of transfused INTERCEPT RBCs
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).
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.