(P-TS-106) Transfusion Of Hypoxic Red Blood Cells To Hematologic Malignancy And Acutely Bleeding Burn Patients

Exposure to oxygen during the storage of red blood cells (RBC) results in decreased quality of the cells known as storage lesions. Hypoxic storage, where the oxygen content of RBC units is reduced to < 20% saturation of O₂ (SO₂) and maintained throughout storage, reduces the accumulation of oxidative and metabolic storage lesions, preserves RBC deformability, and improves oxygen off-loading.

Study

Design/Methods:

An FDA cleared device (CPD/PAGGSM leukocytes-reduced (LR), O₂/CO₂ reduced) to process and store RBC at a saturation of O₂ (SO₂) to < 20% was utilized to assess the safety of single administration of hypoxic RBCs (HRBC) in transfusion-dependent hematologic malignancy (CHRONIC) and acutely bleeding burn (ACUTE) patients.

In the CHRONIC group, a hemoglobin (Hgb) transfusion trigger < 9 g/dL, expectation to receive > 2 units RBCs in a single transfusion event and a diagnosis of MDS/hematologic malignancy were required. In the ACUTE group, adult patients with Total Body Surface Area (TBSA%) burn ≥ 10% and ≤ 50% who were expected to require > 2 unit of red blood cells in a single transfusion event were included.

Safety and tolerance data up to 24 hours following the transfusion event and up to 7 days (+/- 1 day) after were recorded. Secondary objectives included adverse events (AEs) up to the subsequent transfusion event or 28 days (± 1 day) post-transfusion, whichever occurred first. Additionally, changes in Hgb levels post-transfusion were assessed.

Results/Findings:

A single center enrolled 10 CHRONIC and 10 ACUTE patients following approval by the Medical and Health Research Ethics Committee. All CHRONIC patients received one 2-hour transfusion of two units HRBC instead of their usual two units of conventionally stored RBCs (CRBC). ACUTE patients received two units of HRBC but could also receive CRBC if indicated. Individual patient characteristics and AE frequency are shown in Table 1.

In the CHRONIC group of anemic patients, Hgb levels increased by 15% following administration of HRBC while the ACUTE group demonstrated a 2% Hgb increase, illustrating intra-operative blood loss replacement.  Four patients experienced 9 AEs in the CHRONIC group while 13 AEs were reported in 6 patients in the ACUTE cohort. One patient experienced 2 SAEs, wound infection and oliguria.  None of the AEs were deemed related to the blood product or device.

Conclusions:

This pilot study did not demonstrate any safety issues related to HRBC. Additionally, Hgb levels were within the target range at follow-up, suggesting that HRBC function appropriately. The overall clinical program will assess the benefits of transfusion with HRBC versus CRBC in patients requiring acute and chronic transfusions.