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Summary  Transfusion‐dependent thalassaemia ( TDT ) requires red blood cell concentrates ( RBCC ) to prevent complications of anaemia, but carries risk of infection. Pathogen reduction of  RBCC  offers potential to reduce infectious risk. We evaluated the efficacy and safety of pathogen‐reduced ( PR ) Amustaline‐Glutathione (A‐ GSH )  RBCC  for  TDT . Patients were randomized to a blinded 2‐period crossover treatment sequence for six transfusions over 8–10 months with Control and A‐ GSH ‐ RBCC . The efficacy outcome utilized non‐inferiority analysis with 90% power to detect a 15% difference in transfused haemoglobin (Hb), and the safety outcome was the incidence of antibodies to A‐ GSH ‐ PR ‐ RBCC . By intent to treat (80 patients), 12·5 ± 1·9  RBCC  were transfused in each period. Storage durations of A‐ GSH  and C‐ RBCC  were similar (8·9 days). Mean A‐ GSH ‐ RBCC  transfused Hb (g/kg/day) was not inferior to Control (0·113 ± 0·04 vs. 0·111 ± 0·04,  P  = 0·373, paired  t ‐test). The upper bound of the one‐sided 95% confidence interval for the treatment difference from the mixed effects model was 0·005 g/kg/day, within a non‐inferiority margin of 0·017 g/kg/day. A‐ GSH ‐ RBCC  mean pre‐transfusion Hb levels declined by 6·0 g/l. No antibodies to A‐ GSH ‐ RBCC  were detected, and there were no differences in adverse events. A‐ GSH ‐ RBCC s offer potential to reduce infectious risk in  TDT  with a tolerable safety profile.

Amustaline‐glutathione pathogen‐reduced red blood cell concentrates for transfusion‐dependent thalassaemia