Known Blood Safety Issues with Residual Leukocytes

Leukoreduction does not remove all donor leukocytes. Viable leukocytes can cause transfusion-associated graft versus host disease (TA-GVHD) when transfused to susceptible recipients. Gamma irradiation is typically performed only when the recipient risk is recognised.

Leukocytes can produce cytokines during storage, creating the potential for an acute transfusion reaction in recipients. In addition, leukocytes may harbour cell-associated pathogens, such as EBV, CMV, HTLV, chikungunya, or HIV.

No reported cases of TA-GVHD were observed in clinical trials or extensive post-marketing and routine use clinical experience, where haematology/oncology patients at risk for TA-GVHD were supported with INTERCEPT™ platelets without gamma irradiation. Pathogen inactivation using the INTERCEPT Blood System can be used as an alternative to gamma irradiation to prevent TA-GVHD.