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.
Parallel
30-40 mL of INTERCEPT RBCs
DeviceTransfusion of fresh (≤14 days old) allogeneic INTERCEPT RBCs, or \~30 mL of INTERCEPT RBCs plus 10 mL biotinylated INTERCEPT RBCs Transfusion of fresh (≤14 days old) allogeneic INTERCEPT RBCs, in subjects with a history of antibodies to INTERCEPT RBCs.
~30 mL of INTERCEPT RBCs plus plus 10 mL biotinylated INTERCEPT RBCs
DeviceTransfusion of fresh (≤14 days old) allogeneic INTERCEPT RBCs, or \~30 mL of INTERCEPT RBCs plus 10 mL biotinylated INTERCEPT RBCs Transfusion of fresh (≤14 days old) allogeneic INTERCEPT RBCs, in subjects with a history of antibodies to INTERCEPT RBCs.
Acute or delayed hemolytic transfusion reactions
Incidence of acute or delayed hemolytic transfusion reactions (AHTR or DHTR) attributed to the study INTERCEPT RBC transfusion, based upon clinical and/or laboratory findings, using Centers for Disease Control (CDC) Hemovigilance criteria.
Clearance
Incidence of rapid clearance (complete clearance by Day 30) of INTERCEPT RBCs assessed by flow cytometry.
Increase in Antibody Titer
Incidence of ≥4-fold increase in titer of INTERCEPT RBC antibodies from baseline (≥2 doubling dilution increase in titer), indicative of a secondary immune response.
In vivo recovery and survival kinetics
In vivo recovery and survival kinetics of INTERCEPT RBCs (PTR24, lifespan, T50 and AUC) in the presence and absence of INTERCEPT RBC antibodies. In vivo recovery and survival kinetics of INTERCEPT RBCs (PTR24, lifespan, T50 and AUC) in the presence and absence of INTERCEPT RBC antibodies.
Immunoglobulin subclass of INTERCEPT RBC-bound antibodies
Presence of and immunoglobulin subclass of INTERCEPT RBC-bound antibodies assessed by flow cytometry.
RBC alloantibodies or autoantibodies
RBC alloantibodies or autoantibodies not specific to INTERCEPT RBCs that develop during the study period.
Proportion of subjects with Adverse Events (AEs)
Proportion of subjects with AEs (non-serious and serious) documented from the start of the study RBC transfusion up to 24 hours after transfusion of any INTERCEPT RBC challenge.
Proportion of subjects with related AEs
Proportion of subjects with possibly, probably, or definitely related adverse events (i.e., transfusion reactions \[TR\]) documented from the start of the study RBC transfusion until the end of Day 90 (+/- 7 days).
Proportion of subjects with study transfusion related serious adverse events (SAEs)
Proportion of subjects with study transfusion possibly, probably, or definitely related SAEs documented from the start of the study RBC transfusion until the end of the 90-day (+/- 7 days) post-transfusion monitoring period.
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