J Blood Med. 2026 Jun 12;17:573232. doi: 10.2147/JBM.S573232. eCollection 2026.
ABSTRACT
PURPOSE: Red blood cell (RBC) transfusion is frequently given for patients with chronic anemias or acute bleeding after injury or surgery. A CE mark-certified and Food and Drug Administration authorized storage system (Hemanext ONE®; Hemanext Inc. Lexington, MA, United States) has been developed to process and store leukocytes-reduced, O/CO reduced RBCs under hypoxic conditions to improve RBC quality for transfusion. This prospective, open-label, single-center pilot safety study investigated the safety of hypoxic RBCs in 2 patient groups: hematological malignancies and acute burns.
PATIENTS AND METHODS: The primary outcome was the number of patients who experienced an adverse event (AE) within 24 hours of transfusion and overall up to 7 days (±1 day) post-transfusion. Secondary outcomes included changes in hemoglobin (Hb) levels post-transfusion.
RESULTS: Twenty patients (10 with hematological malignancies, 10 with surgical bleeding during burn excision) aged 27-96 years were included (17 males; 8 with hematological malignancies, 9 with burns and 3 females; 2 with hematological malignancies, 1 with burns). All patients in the hematological malignancies group received 2 units of hypoxic RBCs. Patients in the burn group received a mean ±standard deviation (SD) of 1.8 ±0.4 units of hypoxic RBCs. No AEs related to hypoxic RBC transfusion were reported. The mean ±SD changes in Hb from baseline to 15-60 minutes post-transfusion were 1.2 ±0.5 g/dL (hematological malignancies group) and 0.3 ±1.0 g/dL (burn group).
CONCLUSION: This cohort analysis showed that transfusion with hypoxic RBCs processed with the Hemanext ONE storage system was safe and well tolerated in both cohorts.
PMID:42311511 | PMC:PMC13271058 | DOI:10.2147/JBM.S573232