Extended Hemorrhagic Shock Treatment with a Novel Oxygen Carrier Solution
Abstract
Objective/Rationale: In 2012, the Centers for Disease Control and Prevention (CDC) reported that the leading preventable cause of death in people under the age of 45 was due to trauma, with the primary cause of death due to hemorrhagic blood loss. This includes tissue oxygen deprivation and a dramatic decline in blood volume, both of which lead to cardiac failure. Without rapid resuscitation, uncontrolled blood loss is fatal. Whole blood or isolated red blood cells, i.e., the blood oxygen-carrying cellular component, are not viable for transfusion under conditions outside of hospital-controlled storage and cross-matching facilities. Currently, transport of blood to sites of uncontrolled hemorrhage remains unobtained in far-forward military and non-urban civilian environments. The objective of this proposal is to prevent death from hemorrhagic shock in transit before reaching hospital care. Therefore, rapid deployment of a stable, transportable, live-reviving oxygen-carrying solution could save battlefield and civilian population lives. Topics to Be Addressed: Combat Casualty Care Research Program Multi-Domain Lifesaving Trauma Innovations Award Sub-Area(s) to Be Addressed. This proposal addresses Focus Area 1, “Innovative capabilities to enable the provision of damage control interventions closer to point of need,” and “Optimizing sustained (more than 12 hours) resuscitation for hemorrhagic shock,” as well as Focus Area 2, “Novel blood products and/or expanders with oxygen-carrying capacity that offer physiological, logistical, or cost advantages over current products with an intent to support large-scale MDO and high demand during peak conflicts.” To address this critical unmet medical need to treat traumatic blood loss, VirTech Bio (VTB) is developing a novel blood-loss resuscitation fluid that is a hemoglobin-based oxygen carrier (HBOC), such that hemoglobin is the red blood cell protein that transports oxygen from air into lungs to circulate and oxygenate tissues to maintain tissue viability. HBOCs have been designed for clinical benefits of ease use in administration pre-hospital for either military battlefield or civilian ambulance transport to hospital care. VTB’s new and novel HBOC is VIR-HBOC, which provides, in a sustained fashion, oxygen delivery and blood volume expansion as ongoing treatment before blood loss is stanched and recovered. VIR-HBOC is a sterile, room-temperature stable hemoglobin derivation isolated from red blood cells that does not require cross-matching. VIR-HBOC circulates in blood vessels throughout the body to provide immediate restoration of blood volume and urgent oxygen delivery to tissues under threat of oxygen deprivation. To address cessation of ongoing blood loss, VTB also proposes here to integrate potential beneficial effects from the addition of the coagulation plasma factors. Impact – Benefit to Service Members/Public: Adverse effects of pre-VIR-HBOCs in clinical applications have been studied for decades. Early HBOCs demonstrated logistical advantages, but they also revealed physiologic complications, including blood pressure and cardiovascular effects that have thus far prevented Food and Drug Administration (FDA) approval for those early HBOC designs. To address these issues, VIR-HBOC has so far demonstrated resuscitation benefits in small animals that showed a lack of complications exhibited with the earlier products. A critical characteristic of VIR-HBOC is its large molecular size that keeps the solution circulating in the vasculature. VIR-HBOC is room-temperature stable and packaged in a standard blood bag container ready for immediate administration. As such, it is our goal to examine if VIR-HBOC +/- plasma coagulation factors will provide safe and effective resuscitation in a larger animal model of hemorrhagic shock (swine) to simulate pre-hospital settings en route in both military and civilian situations, where rapid resuscitation and cessation
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Mar 10, 2021
- Source ID
- W81XWH2010422
Entities
People
- William Light
Organizations
- United States Army