Hypoxic-hypocapnic red blood cells in PAGGSM additive solution before and after gamma irradiation show improved...

Hypoxic/hypocapnic (HH) treatment and storage conditions have been shown to reduce oxidative stress and improve red blood cell (RBC) quality. This study aimed to validate a good manufacturing practice HH RBC product for obtaining the licence for routine use in patients, by comparison with normoxic RBCs both without irradiation and after gamma irradiation.

Forty-four units of leucoreduced red cell concentrates (LR-RCCs) were prepared from 500 mL citrate-phosphate-dextrose (CPD)/phosphate-adenine-glucose-guanosine-saline-mannitol (PAGGSM) whole-blood donations. Paired units of ABO-matched LR-RCCs were pooled and split into equal aliquots. Twenty-two units (control) were maintained at room temperature for 3 h, while 22 units underwent HH treatment for 3 h using the Hemanext ONE® system. Eleven control and 11 HH LR-RCCs were assigned to the non-irradiated arm, and the remaining 22 units (11 control, 11 HH) were irradiated on Day 14. In vitro RBC quality was measured until Day 42 (non-irradiated) and Day 28 (irradiated on Day 14).

The HH product was comparable to controls in haemoglobin (Hgb) content, haematocrit, potassium and haemolysis, both without irradiation over 42 days and after irradiation over 28 days. HH RBCs contained 1.2-fold higher adenosine triphosphate (ATP) and up to 6.2-fold higher 2,3-diphosphoglycerate (2,3-DPG) levels. Lactate was 25% increased, and glucose levels were up to 30% decreased compared with normoxic RBCs.

HH storage enhanced RBC ATP and 2,3-DPG levels and yielded a product fulfilling RBC quality criteria for the other parameters. These findings support its clinical use for optimizing RBC transfusion quality, particularly for irradiated units.