Ensuring a regular and quality blood supply is a constant challenge for healthcare systems worldwide. In the US, according to data from the American Red Cross, a mere 3% of citizens normally donate blood even though 38% of the population are eligible to donate; Every two seconds, someone requires a transfusion; And a single donation could save as many as three lives. The current US blood supplies can barely meet the needs of patients, many of whom rely on transfusions to survive, either because of severe trauma, life-threatening medical conditions, or surgical complications. In times of national emergencies, such as pandemics or major natural disasters, the lack of sufficient supplies can lead to unnecessary loss of life, exacerbating already tragic situations. Hence, the strong advocacy from the medical and scientific communities for the development and use of blood substitutes, such as the oxygen-carrying solution Hemopure, manufactured by Hemoglobin Oxygen Therapeutics, a clinical-stage biotech company headquartered in Souderton, PA.
While clinicians have been able to use evidence-based medical and surgical concepts to optimize hemostasis and minimize blood loss in an effort to improve patient outcomes, the number of donors over the past few years has dropped significantly, more than negating any savings. An additional risk, this time to the safety of US blood supply, is that despite what officials describe as near-Herculean efforts to screen donated blood for the emerging viruses, the nation’s blood supply is not immune from contaminations as was the case a few years ago when the CDC announced that several cases of West Nile illness were attributed to blood transfusions that contained tainted blood.
The push to develop alternatives to traditional blood transfusions has intensified in the 21st century amidst the global population growth and aging, the emergence of new infectious agents, and the seemingly rising number of natural disasters due to climate change. Not only is the number of donors insufficient to meet demand, but the nature of blood is such that it cannot be readily stockpiled, as refrigerated blood has a shelf-life of only 42 days. With multiple positive medical journal articles already published on Hemopure, its characteristics – including no blood typing or cross matching as well as three-year stability without the need for refrigeration – are ideal for out-of-hospital applications and stockpiling for national emergencies. It is no surprise then that the US Department of Defense is funding a large prehospital clinical trial to evaluate use of Hemopure as a resuscitation fluid in conjunction with freeze-dried plasma.
Currently, Hemopure is stocked and used at several hospitals as an investigational product, under FDA’s authorized expanded access protocols, for the treatment of severe anemia when blood transfusions are not an option. Interestingly, regulatory authorities in South Africa and Russia have already granted market approval for Hemopure for the treatment of perioperative anemia. “While blood transfusion will always be the gold standard of treatment, there is also an obvious need for alternative products, such as Hemopure, in our healthcare system and emergency preparedness,” experts at BloodSupplySolution.com assert. “Stakeholders in government, academic medicine and industry should find a way to work together to make this happen proactively rather than reactively.”