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Northfield Laboratories
Download PDF Members: Northfield Laboratories Inc. is a leader in developing an oxygen-carrying red blood cell substitute for the treatment of life-threatening blood loss, when an oxygen-carrying fluid is required and red blood cells are not available. Northfield’s product, PolyHeme®, is a human hemoglobin-based temporary oxygen-carrying red blood cell substitute. PolyHeme® simultaneously restores lost blood volume and hemoglobin levels and is designed for rapid, massive infusion. PolyHeme® requires no cross-matching. It is compatible with all blood types and therefore immediately available for infusion. It has an extended shelf life in excess of 12 months. PolyHeme® has been rapidly infused in trauma patients during urgent life-threatening blood loss in sufficiently large quantities to be considered well-tolerated in this patient population. Patient enrollment is now complete in a landmark Phase III, randomized, controlled open-label, multicenter, parallel group study to evaluate the safety and efficacy of PolyHeme® when used to treat severely injured patients in hemorrhagic shock before they reach a hospital. Under the protocol, treatment began at the scene of the injury or in the ambulance, and continued during transport and a 12 hour post-injury period in the hospital. The use of PolyHeme® in this setting has the potential to address a critical, unmet medical need. The study is based on two potential life-saving benefits. The first is starting infusion of an oxygen-carrying fluid at the scene of injury and continuing during transport to the hospital. Because blood is not routinely carried in ambulances, PolyHeme® represents a potential improvement over the current standard of care. The second opportunity is the potential to improve the outcome associated with the use of donated blood in the early hospital period in critically injured patients. Although blood is the current standard of care, there is a growing body of scientific evidence pointing to the adverse immunomodulatory effects of early blood transfusion in trauma patients, specifically the incidence of multiple organ failure and the resultant associated mortality. There are also published data indicating that these same effects may not occur with PolyHeme®. Thus while blood is available in the hospital, PolyHeme® is being evaluated as a potential better alternative for the early care of the injured patient.
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