The use of haemoglobin glutamer-250 (HBOC-201) as an oxygen bridge in patients with acute anaemia associated with surgical blood loss

Abstract

For the treatment of substantial blood loss in surgery, allogeneic blood is transfused to maintain stability and organ perfusion and function. Continued concerns about the availability, safety, efficacy and storage-related problems of allogeneic blood products have led to an intense effort to find alternatives that can serve the same physiologic functions. Haemoglobin-based oxygen carriers (HBOCs) are compounds that can match the oxygen-carrying capacity of red blood cells (RBCs), and several HBOCs have reached advanced stages of development and clinical testing. Multi-centre, randomised, Phase III, controlled trials have demonstrated the safety and efficacy of haemoglobin glutamer-250 (bovine) (Hemopure), Biopure Corporation, Cambridge, MA, USA), also known as HBOC-201. HBOC-201 is bovine-derived, modified haemoglobin that has been ultrapurified to remove any plasma proteins, RBC stroma and potential pathogenic material. During the manufacturing process, crosslinking and polymerisation stabilise the haemoglobin molecule, which increases its vascular persistence as well as the efficiency of oxygen transport to tissue. Results from clinical trials indicate that HBOC-201 can be used as an oxygen 'bridge' for patients experiencing anaemia due to surgical blood loss, until their own red blood cells are replenished or have regenerated (haematinic effect). HBOC-201 is generally well-tolerated and is approved for use in South Africa, where it is indicated for use in adult surgical patients who are acutely anaemic, and is used to eliminate, delay or reduce the need for allogeneic RBCs. A Biologics License Application for HBOC-201 is currently under review by the US FDA.