Table 1.
Exclusion criteria
| Patients will be excluded if they meet any of the following criteria prior to randomization: |
| 1. Confirmed positive baseline serum/plasma antibody specific for amustaline/GSH-treated RBCs |
| 2. Pregnant or breast feeding |
| 3. Refusal of blood products or other inability to comply with the protocol in the opinion of the investigator or the treating physician |
| 4. Treatment with any medication that is known to adversely affect RBC viability, such as, but not limited to, dapsone, levodopa, methyldopa, nitrofurantoin, and its derivatives, phenazopyridine and quinidine |
| 5. Planned cardiac transplantation |
| 6. Left ventricular assist device (LVAD) or extracorporeal membrane oxygenation (ECMO) support pre-operatively or a planned need post-operatively |
| 7. Cardiogenic shock requiring pre-operative placement of an intra-aortic balloon pump |
| 8. Active autoimmune hemolytic anemia |
| 9. Planned use of autologous or directed donations |
| 10. RBC transfusion during current hospitalization within 7 days prior to randomization |
| 11. Participation in an interventional clinical study concurrently or within the previous 28 days |
| 12. Patients with a current diagnosis of either chronic kidney disease or acute kidney injury requiring RRT and/or with sCr ≥ 1.8 mg/dL at screening |
| 13. Patients with a current diagnosis of either chronic or acute hepatic insufficiency and a total serum bilirubin ≥ 2.0 mg/dL (≥ 34.2 µmol/L) |
| 14. Pre-existing RBC antibodies that make the provision of compatible study RBC components difficult, at the investigator’s discretion |
| 15. History of TRs requiring washed RBCs, volume-reduced RBCs, or RBCs with additive solution removed |
| 16. Patients with documented IgA deficiency or a history of severe allergic reactions to blood products |
| 17. Patients who require irradiated RBC blood components |
| 18. Positive DAT with a polyspecific DAT reaction strength > 2 + , or any polyspecific DAT with pan-reactivity with a commercial IAT antibody screening panel that precludes the identification of underlying alloantibodies or indicates the presence of autoantibody |