A Clinical Investigation of Hypoxic Red Blood Cell Administration in Patients with Transfusion-Dependent
Håkon Reikvam1,2, Turid Helen Felli Lunde3,4, Einar Klæboe Kristoffersen2,3
1Department of Clinical Science, University of Bergen, Bergen, Norway.
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, O2/CO2 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.
Related Concept Videos
01:22Bone Marrow Sampling and Transplants
The transplant begins with high doses of chemotherapy and radiation treatment, which aim to destroy the...
01:23Hypoxia
Types of Hypoxia
There are four primary types of hypoxia, each resulting from a different cause:
1. Anemic hypoxia: This type occurs due to insufficient oxygen delivery caused by a lack of red blood cells (RBCs) or RBCs with abnormal or...
01:15Blood Transfusion
Blood Transfusion Overview
A blood transfusion is a medical procedure used to replace blood lost due to injury, surgery, or to treat conditions such as anemia or cancer. During a transfusion, donor blood is...
02:45Blood Transfusion and Agglutination
History
The history of blood transfusion dates back to the 17th century, when early attempts were made in animals. In 1818 James Blundell, a British doctor, performed the first successful human blood transfusion. Later in 1900, Karl...
01:14Erythropoiesis