Demonstration of the Safety and Efficacy of a Field-Ready Blood Group Antibody BGA Adsorber in a Porcine Universal Transfusion Model
Abstract
Blood is typed into four major groups, A, B, AB and O, depending on the presence or absence of the A or B antigens on a person’s red blood cells. Anti-A and/or anti-B antibodies are found in the plasma of people that do not carry A or B antigens that can break open the red blood cells of a mismatched donor; therefore, blood products must be appropriately matched in transfusions to prevent serious and life-threatening reactions. Plasma from AB donors and whole blood from O-type donors with low levels of anti-A or anti-B antibodies, i.e., low titer O whole blood (LTOWB), can be transfused regardless of the recipient’s blood type. These universal blood products are frequently used for emergency resuscitation massively bleeding hospital trauma patients and Warfighters with combat casualties. However, supply shortages are common, and the additional donor testing that is required to measure antibody titers may not be practicable in an emergency. To address this need, CytoSorbents developed a compact, lightweight filter to remove anti-A and anti-B antibodies from plasma and whole blood to cost-effectively generate universal plasma from any donor or LTOWB from any O donor. The outcome will be the development of a safe, easy-to-use device that can simplify blood handling and storage, reduce transfusion costs, and eliminate risk from transfusion errors caused by ABO mismatching to benefit patients treated at emergency trauma centers and far-forward military medical units. The objective of this proposal is to validate the safety and efficacy of the final, finished BGA adsorber device in a preclinical study in pigs. Pigs, which are used extensively in trauma and hemorrhage preclinical studies, have a similar blood group system to humans with A and O blood types. Pigs do not have a B blood type. Therefore, we propose validating the safety and efficacy of the final, finished BGA adsorber in a blinded, randomized Good Laboratory Practices (GLP) preclinical study whereby blood will be collected from high anti-A titer O blood group animals, filtered through either the BGA adsorber or a sham device, and transfused into type A animals. The proposed blood group antibody adsorber directly addresses the hemorrhage control focus area need for safer, more effective, and more logistically supportable blood products to treat combat-related and trauma-induced injuries in the pre-hospital setting. The compact, lightweight BGA adsorber will provide medics and emergency medical personnel the ability to stabilize casualties with life-threatening hemorrhagic emergencies in the pre-hospital setting without logistic complications from blood typing. This proposal addresses the needs across the spectrum of emergency care, including field resuscitation and advanced surgical care and hospital-based care. Medics treating causalities far forward or during transport could utilize the device to rapidly reduce the BGA antibodies in blood from walking blood bank donors for hemorrhage control and resuscitation. Additionally, antibody depleted blood shipped from the continental U.S. could be administered at any stage in theater or used stateside in civilian or Department of Veterans’ Affairs hospitals to resuscitate hemorrhaging surgical or trauma patients. The GLP porcine preclinical study will provide a firm understanding of the safety and efficacy of the compact BGA-adsorber and will comprise a key section of an ensuing regulatory submission to the FDA before testing is done in humans. This testing is instrumental for ultimate FDA approval and subsequent transition for deployment to far-forward military and disaster environments and Armed Services and civilian blood centers. Increased availability of universal blood products will allow military efforts to more readily get the right blood to the right place at the right time in the right amount. Military blood product depots would no longer have to stock multiple blood type units for each
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 28, 2022
- Source ID
- W81XWH2210235
Entities
People
- Maryann C Gruda
Organizations
- CytoSorbents (United States)
- United States Army